Teriparatide

FDA status

FDA-approved, and approved more than once: Drugs@FDA returns five applications with teriparatide as an active ingredient, recorded with their own source under fdaFindings. Approval is always for a specific indication and population, and here the population gating is unusually tight — see the approval record below, where every one of the three indications is restricted to patients at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. Teriparatide is a second-line drug on its own label.

Evidence

Administration check RUN, not assumed. The Neer 2001 record was opened on 2026-08-02: 1637 postmenopausal women with prior vertebral fractures were randomly assigned to receive parathyroid hormone (1-34) or placebo, ADMINISTERED SUBCUTANEOUSLY by the participants themselves. The drug was given to people. It was not measured as an endogenous biomarker — the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero, and a trap this compound is unusually exposed to, since parathyroid hormone is an endogenous hormone that appears in thousands of papers as an assay result rather than an intervention. THE TRIALS, NAMED. Three are described in section 14 of the FORTEO label and all three were read there: (14.1) the trial published as Neer 2001, double-blind, multicenter, placebo-controlled, 1637 postmenopausal women with osteoporosis; (14.2) a double-blind, multicenter, placebo-controlled trial of 437 men with primary (idiopathic) or hypogonadal osteoporosis; (14.3) a randomized, double-blind, ACTIVE-controlled trial of 428 patients with glucocorticoid-induced osteoporosis, 19% men and 81% women, aged 22 to 89 years, of 18 months' duration. A DISCREPANCY WORTH RECORDING because it is the kind of thing that gets flattened: the label reports a median EXPOSURE of 19 months for 14.1, while the publication reports a median duration of OBSERVATION of 21 months. Those are different quantities and neither document is wrong. SCOPE, and it is narrow. The tier attaches to the approved products and to the three approved indications. Only 14.1 carried fracture endpoints; the label states the primary efficacy endpoint of 14.2 was change in lumbar spine bone mineral density, and 14.3 is reported on bone mineral density, with the label stating that active-comparator data are not presented because of 'differences in mechanism of action (anabolic vs. anti-resorptive) and lack of clarity regarding differences in BMD as an adequate predictor of fracture efficacy'. Fracture-reduction evidence and bone-density evidence are not the same evidence, and the label does not treat them as such. Nothing here transfers to unapproved material sold as 'PTH 1-34'.

What FDA actually approved

Application

NDA 021318 (FORTEO, Eli Lilly and Company; approved 2002-11-26) — Forteo

Approved indication

FORTEO is indicated: • For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures. • To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. • For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy … at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

On the discontinuation

FORTEO is marketed, so this is false — but Drugs@FDA records TWO products under NDA 021318 and only one of them is current: the smaller-volume prefilled pen carries marketing status Prescription, and the larger-volume presentation carries marketing status Discontinued. 'Forteo is discontinued' and 'a Forteo presentation is discontinued' are different statements and the second one is the true one.

Verbatim from section 1 of the current FORTEO label, with ONE elision, marked with an ellipsis: the third bullet's parenthetical defines the qualifying glucocorticoid exposure as a specific milligram-per-day prednisone equivalent. That is an amount next to a frequency, so it is removed under this site's no-dosing policy even though it describes a different drug and even though it appears inside an FDA indication. No part of the indication depends on the elided figure. Nothing else is altered. READ THE GATING, because it is the gap this field exists to expose. All three indications are second-line on their face — each one requires that the patient be at high risk for fracture OR have failed or be intolerant of other available osteoporosis therapy. There is no first-line indication and no 'bone health' indication. The fracture-reduction sentence in bullet one is the LABEL'S OWN wording, quoted as such; it is confined by its own terms to postmenopausal women with osteoporosis. Also note the header on this label: 'Initial U.S. Approval: 1987', which antedates NDA 021318 by fifteen years. That observation and what Drugs@FDA shows alongside it are recorded under fdaFindings rather than explained here, because the connection between the two is not established by any document read for this record.

What FDA found

FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.

• FDA approved NDA 021318 supplement S-054 on 2020-11-16. The supplement approval letter states that the supplemental application provides for removal of the Boxed Warning regarding osteosarcoma; modification of the Recommended Treatment Duration section to allow for longer duration of treatment in patients who remain at or return to having a high risk for fracture; addition of the risk of cutaneous calcification including calciphylaxis to the existing warning regarding hypercalcemia and hypercalcemic disorders; and revision of the Postmarketing Experience section to reflect the findings from the long-term osteosarcoma surveillance studies.

  The single most useful document on this record, and it runs against the direction this site's findings usually run: a regulator making a label LESS restrictive on the strength of accumulated human data. Read the letter's own structure, because it is not a one-way relaxation — item (c) ADDS a risk (calciphylaxis and cutaneous calcification) at the same time item (a) removes the boxed warning. FDA traded a rodent-derived warning for a human-derived one. This entry is the source for a claim made nowhere else in this library, so it is quoted at length rather than summarised: the boxed warning is GONE. Any page still describing Forteo as a black-box drug is describing the label as it stood before 16 November 2020. Cross-checked directly against the current labeling — the 2024 prescribing information (S-057) contains zero case-insensitive matches for 'boxed warning', and the SPL served by openFDA carries no boxed-warning section at all.

  NDA 021318/S-054 Supplement Approval Letter — Forteo (teriparatide injection) — FDA, 16 November 2020

  “This Prior Approval supplemental new drug application provides for: a. Removal of the Boxed Warning regarding osteosarcoma. b. Modification of Section 2.3 (Dosage and Administration, Recommended Treatment Duration) to allow for longer duration of treatment in patients who remain at or return to having a high risk for fracture. c. Addition of the risk of cutaneous calcification including calciphylaxis to the existing warning regarding hypercalcemia and hypercalcemic disorders d. Revision of Section 6.3 (Adverse Reactions, Postmarketing Experience) to reflect the findings from the long-term osteosarcoma surveillance studies.”

  Checked against the source on 2 August 2026.

• The original FORTEO labeling approved in 2002 carried a boxed warning stating that in male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration, and that because of the uncertain relevance of the rat osteosarcoma finding to humans, teriparatide should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. That boxed warning was removed by supplement S-054, approved 2020-11-16.

  Recorded to make the removal checkable in both directions. A claim that something was removed is only as good as the evidence it was ever there, and 'everyone knows Forteo had a black box' is not evidence — so the superseded 2002 labeling is cited directly. The document carries Lilly's own notice that 'This label may not be the latest approved by FDA', and it is used here for exactly that reason: it is the historical record, not the current one, and this record never presents it as current. QUOTE HANDLING: one sentence is elided, marked with an ellipsis. It expressed the rat exposures as multiples of a specific human microgram dose, which is an amount, so it is removed under this site's no-dosing policy. The finding — rat osteosarcoma, dependent on dose and treatment duration, of uncertain human relevance — is intact.

  FORTEO (teriparatide) injection — original approved labeling, NDA 21-318 (superseded) — FDA, 26 November 2002

  “WARNING In male and female rats, teriparatide caused an increase in the incidence of osteosarcoma (a malignant bone tumor) that was dependent on dose and treatment duration. … Because of the uncertain relevance of the rat osteosarcoma finding to humans, teriparatide should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk.”

  Checked against the source on 2 August 2026.

• Drugs@FDA lists five applications with teriparatide as an active ingredient: NDA 021318 (FORTEO, Eli Lilly and Company, approved 2002-11-26); NDA 211939 (BONSITY, Alvogen, approved 2019-10-04); and three abbreviated new drug applications for teriparatide injection — ANDA 208569 (Teva Pharmaceuticals USA, approved 2023-11-16), ANDA 211097 (Apotex, approved 2023-11-16) and ANDA 213641 (Amphastar Pharmaceuticals, approved 2025-12-12). Drugs@FDA records the marketing status of a product under each of the five as Prescription.

  Recorded because 'teriparatide' does not identify a product, and because the ANDAs are the part people miss. An abbreviated new drug application is the generic pathway: three of these five applications exist because FDA accepted teriparatide injection as a drug capable of having generics, which is a materially different regulatory posture from the protein therapeutics this category is usually compared to. Approval dates are the ORIG submission status dates in the same Drugs@FDA response. What this entry does NOT establish: it says nothing about relative price, about substitutability at the pharmacy counter, or about whether any given product is on the shelf today. Marketing status in Drugs@FDA is an application-level record, not a supply report.

  Drugs@FDA — applications with teriparatide as an active ingredient (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on 2 August 2026.

• The current FORTEO label states in its Highlights header 'Initial U.S. Approval: 1987', which is fifteen years earlier than the 2002-11-26 approval of NDA 021318. Drugs@FDA separately lists NDA 019498 (PARATHAR, Sanofi Aventis US), whose active ingredient it records as TERIPARATIDE ACETATE and whose marketing status it records as Discontinued.

  Two verified observations, deliberately left unjoined. The 1987 date is on the label and the discontinued acetate application is in Drugs@FDA, and it is tempting to say the first refers to the second — but no document read for this record says so, and openFDA returns no submission history for NDA 019498, so its approval date could not be confirmed here. Writing the causal sentence would be a guess, and a guess is fatal. What follows regardless, and is the reason this is recorded at all: 'Initial U.S. Approval' on a label is a statement about the ACTIVE MOIETY, not about the product in front of you. Anyone citing 1987 as Forteo's approval date is citing the wrong application by fifteen years, and anyone treating a discontinued acetate product as evidence about the marketed free-base product is making the salt-form error this site documents at length elsewhere. GAP, stated plainly: the indication, sponsor history and reason for discontinuation of NDA 019498 were not established and are not asserted.

  Drugs@FDA — applications with teriparatide as an active ingredient (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on 2 August 2026.

• Teriparatide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.

  Recorded to close a misreading, not to assert a status — which is why this record carries NO compoundingStatus field at all. Verified by fetching the document with a browser user-agent and text-extracting all seven pages on 2026-08-02: zero hits for 'teriparatide', zero for 'parathyroid', zero for 'PTH'. Absence from this list is not a category and not a finding. It cannot distinguish 'nominated then withdrawn' from 'never nominated' from 'approved drug that was never on the nomination track at all', and teriparatide is squarely in that third situation: a 503A bulks nomination is a route for substances that lack an approved product, and teriparatide is the active ingredient in five approved applications. Recording it as 'never-nominated' would imply a proceeding it was never part of, so the field is omitted instead. SCOPE: this entry is about one document. It is not an answer to whether a pharmacy may lawfully compound a teriparatide preparation — that turns on other parts of section 503A, including the essentially-a-copy restriction, and no document read for this record addresses it.

  Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.

Documented safety signals

• Warnings and Precautions, section 5.1 — Osteosarcoma. The label states that an increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide; that osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; that an increased risk of osteosarcoma has not been observed in observational studies in humans; and that there are limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use. The label directs that FORTEO be avoided in patients at increased baseline risk of osteosarcoma: those with open epiphyses (pediatric and young adult patients), metabolic bone diseases other than osteoporosis including Paget's disease of the bone, bone metastases or a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma.

  The osteosarcoma signal did not disappear when the box did — it was RELOCATED to Warnings and Precautions, and both halves of that sentence are load-bearing. This single paragraph holds three claims that are routinely quoted one at a time by people arguing opposite conclusions: rats got tumors; humans on the drug have been reported to get tumors post-marketing; observational studies in humans have not shown an increased risk. All three are in the same paragraph of the same label. The label also states the data beyond 2 years of use are limited, which is a stated gap rather than a reassurance. The avoid-in list is a screening conversation a prescriber has and a purchaser of unapproved material is never asked.

  FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

  “An increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide. Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use”

  Checked against the source on 2 August 2026.

• Adverse Reactions, section 6.3 — the postmarketing osteosarcoma surveillance data. The label reports that two osteosarcoma surveillance safety studies, both U.S. claims-based database studies, were designed to obtain data on the incidence rate of osteosarcoma among FORTEO-treated patients, and that three and zero osteosarcoma cases respectively were identified among 379,283 and 153,316 FORTEO users. The label states the study results suggest a similar risk for osteosarcoma between FORTEO users and their comparators, and that interpretation calls for caution owing to the limitations of the data sources, which do not allow for complete measurement and control for confounders.

  This is the evidence the boxed-warning removal rests on, and the letter approving that removal names it: item (d) of NDA 021318/S-054 provides for revising this very section 'to reflect the findings from the long-term osteosarcoma surveillance studies'. Half a million treated patients across two claims-based studies is a real denominator, which is more than almost anything else on this site has. Read FDA's own caveat rather than the headline: the label states the interpretation 'calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders'. Claims-database studies are not trials. A finding of similar risk is not a finding of no risk, and it does not erase the post-marketing case reports recorded in the same section.

  FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

  “In these two studies, three and zero osteosarcoma cases were identified among 379,283 and 153,316 FORTEO users, respectively. The study results suggest a similar risk for osteosarcoma between FORTEO users and their comparators. However, the interpretation of the study results calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders.”

  Checked against the source on 2 August 2026.

• Warnings and Precautions, section 5.2 — Hypercalcemia and Cutaneous Calcification. The label states that FORTEO has not been studied in patients with pre-existing hypercalcemia, may cause hypercalcemia and may exacerbate hypercalcemia in patients with pre-existing hypercalcemia, and should be avoided in patients known to have an underlying hypercalcemic disorder such as primary hyperparathyroidism. It further states that serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO, that risk factors for development of calciphylaxis include underlying auto-immune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use, and that FORTEO should be discontinued in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.

  The risk FDA ADDED in the same action that removed the boxed warning — item (c) of the S-054 supplement approval letter. Recorded next to the removal deliberately, because a page that reports only the removal reports half of what FDA did. Note the risk factors: warfarin and systemic corticosteroids are common co-medications, and systemic glucocorticoid therapy is the defining feature of the population in the third approved indication.

  FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

  “Serious reports of calciphylaxis and worsening of previously stable cutaneous calcification have been reported in the post-marketing setting in patients taking FORTEO. Risk factors for development of calciphylaxis include underlying auto-immune disease, kidney failure, and concomitant warfarin or systemic corticosteroid use. Discontinue FORTEO in patients who develop calciphylaxis or worsening of previously stable cutaneous calcification.”

  Checked against the source on 2 August 2026.

• Warnings and Precautions, section 5.4 — Orthostatic Hypotension. The label states that in short-term clinical pharmacology studies of FORTEO in healthy volunteers, transient episodes of symptomatic orthostatic hypotension were observed in 5% of volunteers; that these events typically began within 4 hours of dosing and resolved without treatment within a few minutes to a few hours; that when transient orthostatic hypotension occurred it happened within the first several doses, was relieved by placing the person in a reclining position, and did not preclude continued treatment; and that FORTEO should be administered initially under circumstances in which the patient can sit or lie down if symptoms occur. Section 5.3 separately directs that the risks and benefits be considered in patients with active or recent urolithiasis because of the potential to exacerbate this condition, the label noting that FORTEO has not been studied in patients with active urolithiasis.

  Included because it is the labeled risk with an ADMINISTRATION-SETTING instruction attached, and that instruction is the one that silently disappears outside a prescribing relationship. The label's own framing is notably undramatic — transient, self-resolving, early, not a reason to stop — which is exactly why it is recorded verbatim rather than characterised.

  FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

  “In short-term clinical pharmacology studies of FORTEO in healthy volunteers, transient episodes of symptomatic orthostatic hypotension were observed in 5% of volunteers.”

  Checked against the source on 2 August 2026.

• Contraindication — the label states that FORTEO is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients, and that hypersensitivity reactions have included angioedema and anaphylaxis. The Postmarketing Experience section lists anaphylactic reactions, drug hypersensitivity, angioedema and urticaria among adverse reactions identified during postapproval use, and states that hypercalcemia greater than 13 mg/dL has been reported with FORTEO use.

  The label attaches its own caveat to everything in the postmarketing list: 'Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.' Spontaneous reports are a floor of unknown height, not a rate. The 13 mg/dL figure is a reported laboratory VALUE, not a dose.

  FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

  “FORTEO is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis”

  Checked against the source on 2 August 2026.

Questions people actually ask

Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.

Does Forteo (teriparatide) still have a black box warning?

No. FDA removed it. The approval letter for NDA 021318 supplement S-054 states that the supplemental application provides for, first on its list, 'Removal of the Boxed Warning regarding osteosarcoma.' Drugs@FDA records that supplement as approved on 16 November 2020. The current FORTEO prescribing information — the 2024 labeling approved under supplement S-057 — contains no boxed warning at all, and neither does the current structured product label. The risk was not deleted from the label, it was moved: osteosarcoma now appears as Warning and Precaution 5.1. And the same supplement that removed the box ADDED a warning, for cutaneous calcification including calciphylaxis, alongside the existing hypercalcemia warning. Any source describing teriparatide as a black-box drug is describing the label as it stood before 16 November 2020.

NDA 021318/S-054 Supplement Approval Letter — Forteo (teriparatide injection) — FDA, 16 November 2020

“This Prior Approval supplemental new drug application provides for: a. Removal of the Boxed Warning regarding osteosarcoma.”

Checked against the source on 2 August 2026.

What is teriparatide FDA-approved to treat?

Osteoporosis, in three specific populations, and in every one of them only as a second-line option. The FORTEO label indicates it for the treatment of postmenopausal women with osteoporosis at high risk for fracture — defined in the label as having a history of osteoporotic fracture or multiple risk factors for fracture — or who have failed or are intolerant to other available osteoporosis therapy; to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy; and for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. Read the qualifier, because it is in all three: FDA did not approve teriparatide for osteoporosis generally, for low bone density, for bone healing, or for anything a person without osteoporosis would recognise as a goal. The label's own efficacy claim is likewise confined — it states that in postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures, and it makes that fracture claim for no other population.

FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

“FORTEO is indicated: • For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures.”

Checked against the source on 2 August 2026.

Is there a generic version of teriparatide?

Yes. Drugs@FDA lists three approved abbreviated new drug applications for teriparatide injection — ANDA 208569 (Teva Pharmaceuticals USA) and ANDA 211097 (Apotex), both approved 16 November 2023, and ANDA 213641 (Amphastar Pharmaceuticals), approved 12 December 2025 — in addition to the two new drug applications, NDA 021318 (FORTEO, Eli Lilly and Company) and NDA 211939 (BONSITY, Alvogen). Drugs@FDA records a product under each of the five with marketing status Prescription. The abbreviated pathway is the generic pathway, so teriparatide is one of the few peptides discussed in this category that has approved generics at all. What that does not tell you: Drugs@FDA is an application-level record, so it is not a statement about price, about what a given pharmacy stocks, or about substitution rules, none of which this record addresses.

Drugs@FDA — applications with teriparatide as an active ingredient (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on 2 August 2026.

Does teriparatide cause osteosarcoma in humans?

The FDA-approved label does not say it does, and does not say it does not. Section 5.1 holds all three findings in one paragraph: an increase in the incidence of osteosarcoma, a malignant bone tumor, was observed in male and female rats treated with teriparatide; osteosarcoma has been reported in patients treated with FORTEO in the post-marketing setting; and an increased risk of osteosarcoma has not been observed in observational studies in humans. Section 6.3 reports the human data behind that third clause — two U.S. claims-based osteosarcoma surveillance studies identified three and zero cases among 379,283 and 153,316 FORTEO users respectively, results the label says 'suggest a similar risk for osteosarcoma between FORTEO users and their comparators'. The label attaches its own caution to them: interpretation 'calls for caution owing to the limitations of the data sources which do not allow for complete measurement and control for confounders'. The label also states there are limited data assessing the risk of osteosarcoma beyond 2 years of use, and it still directs that teriparatide be avoided in patients at increased baseline risk of osteosarcoma, including those with open epiphyses, Paget's disease of the bone, bone metastases or a history of skeletal malignancies, prior skeletal radiation, and hereditary predisposition. Those human surveillance findings are why the boxed warning came off in 2020 — not a finding that the risk was never real.

FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

“Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use”

Checked against the source on 2 August 2026.

Is teriparatide on FDA's 503A compounding list?

No — teriparatide appears in none of the three categories of FDA's list of bulk drug substances nominated for use in compounding under section 503A, in the version updated 14 May 2026. That was confirmed by fetching the document and searching the extracted text: zero hits for 'teriparatide', zero for 'parathyroid', zero for 'PTH'. Read the absence correctly, because it means something different here than it does for the research-chemical peptides. That list is a nomination track for substances that lack an approved product; teriparatide is the active ingredient in five approved applications, so it was never a candidate for it. Absence is not a category, not a safety finding, and not permission. This record therefore records no 503A compounding status for teriparatide at all, rather than labelling it 'never nominated', which would imply a proceeding it was never part of. Whether a pharmacy may lawfully compound a teriparatide preparation is a separate question turning on other parts of section 503A, and no document read for this record answers it.

Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.

Is teriparatide the same thing as PTH(1-34) sold as a research peptide?

Not established, and the label is the reason to be careful rather than the reason to be confident. Teriparatide is a recombinant human parathyroid hormone analog, PTH 1-34; the FORTEO label states it has 'an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone' and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. So the sequence named on a research vial and the sequence in the approved product are the same sequence. That is where the equivalence stops: a sequence name is not an identity test, and nothing in the documents behind this record establishes the contents, purity, or salt form of any unapproved material. Salt form is not a technicality here — the approved FORTEO product contains teriparatide as a free base, while Drugs@FDA lists a separate discontinued application, PARATHAR (NDA 019498), whose active ingredient it records as teriparatide acetate. The approval, the label and the fracture trial behind the approved product describe that product. They do not describe a vial.

FORTEO (teriparatide injection) — Full Prescribing Information — FDA, 26 July 2024

“FORTEO (teriparatide injection) is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.”

Checked against the source on 2 August 2026.