Exenatide

FDA status

Approved, and the reason that word is right here is narrower than it looks. Every BRANDED exenatide application has had its approval withdrawn — see fdaFindings. What remains is a generic: exenatide injection under ANDA 206697 (Amneal Pharmaceuticals), approved 2024-11-19, which Drugs@FDA lists with marketing status 'Prescription' and for which FDA hosts a current approved label with an SPL effectiveTime of 2026-05-27. The vocabulary's own explainer for `approval-withdrawn` says 'No approved product is on the market'; that is not this compound's situation, so the badge would have been false. ONE DISCREPANCY, RECORDED RATHER THAN RESOLVED. Drugs@FDA also lists NDA 021919 (Byetta, Amylin, approved 2009-10-30 as a Type 6 New Indication) with marketing status 'Prescription'. That application appears in neither Federal Register withdrawal notice, and a full-text Federal Register search for 'NDA 021919' returns nothing. Whether that status is live or stale is not something the documents settle, so this record does not settle it either; the `approved` value does not depend on it, because the Amneal ANDA carries it independently.

Evidence

QUOTE HANDLING: the label names the milligram-equivalent strengths of each arm and their administration frequency. They are elided above with ellipses under this site's no-dosing policy — a dose-to-outcome mapping is the actionable part for someone self-administering an unapproved vial. Nothing else in the quote is altered, and no finding below depends on the elided figures. ADMINISTRATION CHECK RUN, NOT ASSUMED. Section 14 of the current FDA-approved labeling was opened and read on 2026-08-02. Exenatide was injected subcutaneously into randomised human subjects and compared against placebo injected on the same schedule — it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. THE TRIALS, NAMED AS PRECISELY AS THE DOCUMENTS ALLOW. For the approved glycemic indication: a randomised, double-blind, placebo-controlled monotherapy trial of 24 weeks' duration (intent-to-treat n=232 across three arms); three randomised, double-blind, placebo-controlled trials of 30 weeks' duration in patients inadequately controlled on metformin, a sulfonylurea, or both (1,446 patients randomised); and a placebo-controlled trial of 16 weeks' duration adding exenatide to an existing thiazolidinedione with or without metformin (n=233). HONEST LIMITATION: the label does not carry NCT identifiers for these trials, which predate registration practice, so they are named by the label's own description and cannot be independently pulled from a registry by number. ONE TRIAL IS NCT-IDENTIFIED AND WAS CHECKED DIRECTLY. EXSCEL (NCT01144338) was opened on 2026-08-02 via the ClinicalTrials.gov API: study type INTERVENTIONAL, intervention type DRUG, exenatide once weekly versus placebo, Phase 3, enrolment 14,752 ACTUAL, lead sponsor AstraZeneca, status COMPLETED (primary completion 2017-04-21, completion 2017-04-24), hasResults true. SCOPE, AND IT IS THE WHOLE POINT. This tier attaches to the approved indication — glycemic control in adults with type 2 diabetes — and to the approved products. It does not travel to weight loss, for which no exenatide product has ever held an FDA indication; it does not travel to the neurodegenerative-disease uses exenatide is discussed for in the research literature; and it does not travel to unapproved material sold under this name or under 'exendin-4'. EXSCEL is also a caution against inflating the tier: a 14,752-patient cardiovascular outcomes trial ran, and FDA-approved labeling reports it did not meet the superiority test.

What FDA actually approved

Application

ANDA 206697 (exenatide injection, Amneal Pharmaceuticals) — approved 2024-11-19 and the exenatide application whose label is cited here. Drugs@FDA also lists BYETTA under NDA 021919 with marketing status 'Prescription', so this is not the only non-discontinued exenatide record. Approval of NDA 021773 (Byetta), NDA 022200 (Bydureon, Bydureon Pen) and NDA 209210 (Bydureon BCise) has been withdrawn. — Byetta, Bydureon, Bydureon Pen, Bydureon BCise — all withdrawn

Approved indication

Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Exenatide injection contains exenatide. Co-administration with other exenatide-containing products is not recommended.

On the discontinuation

`discontinued` is false because an approved exenatide product is marketed — but the brands are gone, and the manner of their going is the record. FDA withdrew approval of Byetta (NDA 021773), Bydureon and Bydureon Pen (NDA 022200) and Bydureon BCise (NDA 209210) effective 2025-09-03. The Federal Register notice states the applicants informed FDA the products were no longer marketed and requested withdrawal under 21 CFR 314.150(c), and that they waived their opportunity for a hearing. READ WHAT THE NOTICE DOES AND DOES NOT SAY. It gives one stated reason: no longer marketed. It records no safety or effectiveness determination. This site does not read that silence as an endorsement — a withdrawal at the sponsor's request is the absence of a finding, not a finding of absence — and it does not read it as a safety withdrawal either. The notice also states withdrawal under this section is 'without prejudice to refiling'.

The indication is recorded verbatim from the SPL of the product that is actually on the market, because the gap between the approved indication and the marketed use is the point of this field. There is exactly ONE indication, it is gated on 'adults with type 2 diabetes mellitus', and it is conditioned on 'an adjunct to diet and exercise' — the label does not approve exenatide as a standalone therapy. NO EXENATIDE PRODUCT HAS EVER CARRIED A WEIGHT-MANAGEMENT INDICATION. This was checked against all three current or last-approved exenatide labels rather than assumed: the Amneal SPL, the final Byetta SPL and the last Bydureon BCise PDF each carry the glycemic indication and nothing else. That matters because the GLP-1 class is now sold on weight loss, and exenatide's labels do not follow the class. ONE DIFFERENCE WORTH KNOWING: the withdrawn Bydureon BCise label extended its indication to 'adults and pediatric patients aged 10 years and older'. The immediate-release label that survives is adults only. The paediatric indication left the market with the product.

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 withdrew approval of Byetta (NDA 021773), Bydureon and Bydureon Pen (NDA 022200) and Bydureon BCise (NDA 209210) effective September 3, 2025. The applicants informed FDA that the drug products were no longer marketed and requested that FDA withdraw approval under 21 CFR 314.150(c), waiving their opportunity for a hearing.

  The single most load-bearing document on this record, and it is not what the secondary coverage says. 'Byetta was discontinued' describes a commercial decision. This is a regulatory act: the applications no longer exist as approvals. FDA's notice states that 'Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act', while permitting inventory on hand at the effective date to be dispensed until depleted or expired. Verified by reading table 1 of the raw Federal Register text line by line on 2026-08-02; all three application numbers are present. FDA's own typo is in the source, which prints 'Bydrueon BCise'.

  Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications (90 FR 36440) — FDA, 4 August 2025

  “The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). … Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of September 3, 2025.”

  Checked against the source on 2 August 2026.

• FDA listed NDA 022200 (Bydureon, Bydureon Pen) and NDA 209210 (Bydureon BCise) a SECOND time, in a later withdrawal notice stating approval is withdrawn as of April 8, 2026. The same two applications appear in the earlier notice withdrawing approval as of September 3, 2025.

  Recorded because it was found, not because it is explained. Both Federal Register notices were fetched as raw text and searched on 2026-08-02: NDA 022200 and NDA 209210 appear in table 1 of each, with different effective dates and slightly different applicant address blocks. Byetta (NDA 021773) appears only in the 2025 notice. This record does not guess at the cause — a duplicate listing, a re-issuance, or something else — and it does not average the dates. Anyone citing a single withdrawal date for Bydureon should know a second notice exists, because a citation that names one date without knowing about the other is a citation that has not read the documents.

  Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications (91 FR 11321) — FDA, 9 March 2026

  “Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of April 8, 2026.”

  Checked against the source on 2 August 2026.

• FDA issued an order refusing to approve NDA 209053 for ITCA 650 (exenatide in DUROS device), a subdermally implanted osmotic mini-pump delivering exenatide, finding that Intarcia Therapeutics had not demonstrated the product is safe for its intended use.

  A full adjudicated refusal, which is rare and far stronger than a complete response letter. The procedural history in FDA's own notice: NDA submitted 2016-11-21 with three phase 3 trials (CLP-103, CLP-105 and CLP-107, the latter also called FREEDOM, a cardiovascular outcome trial); complete response 2017-09-21; resubmission 2019-09-19; second complete response 2020-03-09; hearing request 2021-03-16; notice of opportunity for a hearing 2021-09-02 (86 FR 49334); final decision 2024-08-23. READ THE SCOPE PRECISELY, because it is easy to over-read in both directions. FDA refused a specific DRUG-DEVICE COMBINATION, not the active ingredient — exenatide by injection was already approved and still is. But the deficiencies were not purely mechanical: FDA's notice records concerns about acute kidney injury, an unresolved cardiovascular risk signal, and drug-delivery variability that 'compare unfavorably to approved products with a similar or identical active ingredient'.

  Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650 (89 FR 68168) — FDA, 23 August 2024

  “FDA finds that the record shows that the approval criteria set forth in section 505(d)(2) of the FD&C Act have not been met, as ITCA 650's risks outweigh its benefits; therefore, Intarcia has not demonstrated that ITCA 650 is safe for its intended use. Therefore, under section 505(d) of the FD&C Act, FDA hereby denies approval to Intarcia's NDA in its current form.”

  Checked against the source on 2 August 2026.

• In EXSCEL, the cardiovascular outcomes trial of exenatide extended-release in 14,752 adults with type 2 diabetes, FDA-approved labeling reported that exenatide extended-release did not increase the risk of major adverse cardiac events, meeting the pre-specified non-inferiority margin but not the superiority test.

  The finding that separates exenatide from the GLP-1 halo, and it is FDA-approved wording rather than a critic's characterisation. Independently corroborated on 2026-08-02 against the posted results for NCT01144338 on ClinicalTrials.gov, which record the same hazard ratio of 0.91 with a 95% confidence interval of 0.832 to 1.004, a superiority p-value of 0.061 against the null hypothesis HR ≥ 1, and a non-inferiority p-value of less than 0.001 against a margin of 1.3. WHY THIS IS WORTH RECORDING: the confidence interval crosses 1.00, so the trial is consistent with no cardiovascular benefit. That is a materially different result from the class members that did establish cardiovascular indications, and it is the reason no exenatide product ever carried one. The trial is also the strongest evidence on this record that a large, well-conducted, completed programme is not the same thing as a positive one.

  BYDUREON BCISE (exenatide) extended-release injectable suspension — Highlights of Prescribing Information (NDA 209210, SUPPL-25) — FDA, 28 May 2025

  “BYDUREON did not increase the risk of MACE in adult patients with type 2 diabetes mellitus (HR: 0.91; 95% CI: 0.832, 1.004; P<0.001 for non-inferiority; P=0.06 for superiority).”

  Checked against the source on 2 August 2026.

• Exenatide 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 PDF with a browser user-agent and text-extracting it locally on 2026-08-02: zero hits for 'xenatide', 'yetta' or 'ydureon' across all seven pages. This absence means something entirely different from BPC-157's absence. BPC-157 was nominated and left Category 2 when the nominators withdrew. Exenatide was never in this system: a 503A bulks nomination is a route for substances without an approved product, and exenatide has one on the market. Categorical silence here is neither permission nor a safety finding.

  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.

• Drugs@FDA records five applications containing exenatide. The original approval, NDA 021773 (Byetta), was approved 2005-04-28 as a Type 1 New Molecular Entity. The generic, ANDA 206697 (Amneal), was approved 2024-11-19 and is listed with marketing status 'Prescription'; both of its products carry therapeutic equivalence code AP and are flagged as reference standard.

  The chronology is the story. FDA approved the generic on 2024-11-19, nine months before the brand it references lost its approval on 2025-09-03 — and Drugs@FDA now flags the GENERIC as the reference standard, the role the brand used to hold. A first-in-class originator exited and its copy became the benchmark. A METHOD NOTE THAT IS ALSO A WARNING. Searching openFDA by `openfda.generic_name` returns only two of these five applications, because the openFDA block is empty or partial on several exenatide records; the query in the source URL uses `products.active_ingredients.name`, which returns all five. A NOT_FOUND from the wrong field is an artifact of the query, not a fact about the database — the same mistake once produced a false 'sermorelin is not in Drugs@FDA' claim in this library. ON 'THE FIRST GLP-1': the 2005-04-28 Type 1 New Molecular Entity approval is primary and sourced. The first-in-class superlative is NOT asserted anywhere in this record, because no single FDA document read here states it. Running the same Drugs@FDA query for other GLP-1 receptor agonists returns later original approvals (liraglutide NDA 022341, 2010-01-25; semaglutide NDA 209637, 2017-12-05; tirzepatide NDA 215866, 2022-05-13), which is consistent with the claim but is a derivation, not a citation.

  Drugs@FDA — applications containing exenatide (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on 2 August 2026.

Documented safety signals

• Boxed warning on the withdrawn extended-release products — risk of thyroid C-cell tumors. Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether exenatide extended-release causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

  Recorded against the extended-release label specifically, and the scoping is the finding. This boxed warning is NOT on the immediate-release exenatide injection that remains on the market — that label carries no boxed warning at all, and no MTC or MEN 2 contraindication. Same active ingredient, different formulation, different highest-level FDA warning. Anyone reasoning 'exenatide has a thyroid boxed warning' or 'exenatide has no thyroid boxed warning' is half right and cannot tell which half without naming the product. The applications carrying this warning had their approvals withdrawn, so the label is archival — it is cited here because it is the primary document and it is still on accessdata.fda.gov.

  BYDUREON BCISE (exenatide) extended-release injectable suspension — Highlights of Prescribing Information (NDA 209210, SUPPL-25) — FDA, 28 May 2025

  “Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCISE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of exenatide extended-release-induced rodent thyroid C-cell tumors has not been determined.”

  Checked against the source on 2 August 2026.

• Contraindication and labeled warning on the marketed immediate-release product — drug-induced immune-mediated thrombocytopenia. Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia has been reported with exenatide use. Exenatide injection is contraindicated in patients with a history of drug-induced immune-mediated thrombocytopenia from exenatide products.

  The exenatide-specific signal, and the one least likely to be known by someone generalising from the GLP-1 class. It is a contraindication, not merely a precaution, and the label instructs discontinuation and avoidance of re-exposure. Note the wording of the contraindication: it is scoped to 'exenatide products' as a class, so a reaction on one exenatide product rules out the others — the kind of cross-product screening question that only exists because there is a label to ask it.

  EXENATIDE injection, for subcutaneous use — Prescribing Information (SPL, ANDA 206697) — FDA, 27 May 2026

  “A history of drug-induced immune-mediated thrombocytopenia from exenatide products. Serious bleeding, which may be fatal, from drug-induced immune-mediated thrombocytopenia has been reported with exenatide use.”

  Checked against the source on 2 August 2026.

• Labeled warnings and precautions on the marketed immediate-release product include acute pancreatitis, hypoglycemia with concomitant use of insulin secretagogues or insulin, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, immunogenicity, hypersensitivity including anaphylaxis and angioedema, drug-induced immune-mediated thrombocytopenia, acute gallbladder disease, and pulmonary aspiration during general anesthesia or deep sedation. The label also instructs that an exenatide injection pen must never be shared between patients, even if the needle is changed.

  Reproduced because 'well-tolerated' does heavy lifting in how this class is sold. The label lists as most common, at 5% or greater and more frequent than placebo in clinical trials: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia, constipation and asthenia. The label also states exenatide is not recommended in patients with severe gastroparesis, and that patients may develop antibodies to exenatide — with the labeled consequence being worsening or failure to achieve target glycemic control, which is a loss-of-effect signal rather than a toxicity one.

  EXENATIDE injection, for subcutaneous use — Prescribing Information (SPL, ANDA 206697) — FDA, 27 May 2026

  “Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including exenatide. Discontinue if pancreatitis is suspected. … Never share an exenatide injection pen between patients, even if the needle is changed.”

  Checked against the source on 2 August 2026.

• In a 104-week rat carcinogenicity study reported in the FDA-approved labeling for immediate-release exenatide injection, benign thyroid C-cell adenomas were observed in female rats at all exenatide dose levels. In a 104-week mouse carcinogenicity study, no evidence of tumors was observed. Exenatide was not mutagenic or clastogenic in the Ames bacterial mutagenicity assay or a chromosomal aberration assay in Chinese hamster ovary cells, and was negative in the in vivo mouse micronucleus assay.

  Recorded because it sits in tension with the boxed-warning asymmetry above and a reader deserves both halves. A rodent thyroid C-cell finding appears in the NONCLINICAL TOXICOLOGY section of the immediate-release label, which carries no boxed warning; the extended-release label carried a boxed warning on a finding described in similar terms. This record does not attempt to explain FDA's line between the two — the exposure multiples, tumour types and formulations differ, and reconstructing a regulatory judgement from two labels would be a guess. The checkable statement is that both findings are in FDA-approved labeling and only one of them was elevated to a boxed warning. Specific dose levels and exposure multiples in the label's text are omitted here under this site's no-dosing policy; no finding above depends on them.

  EXENATIDE injection, for subcutaneous use — Prescribing Information (SPL, ANDA 206697) — FDA, 27 May 2026

  “Benign thyroid C-cell adenomas were observed in female rats at all exenatide doses.”

  Checked against the source on 2 August 2026.

• In FDA's final decision refusing approval of ITCA 650 (exenatide in DUROS device), FDA recorded that more subjects who received ITCA 650 experienced acute kidney injury events than those who received placebo, and that a majority of the serious AKI events in participants randomized to ITCA 650 appeared to be associated with vomiting, diarrhea and dehydration — known adverse reactions associated with exenatide therapy.

  Included because the mechanism generalises even though the product does not. FDA's reasoning links a serious renal outcome to the ordinary gastrointestinal adverse reactions of the class, via volume depletion — which is precisely the pathway the marketed exenatide label warns about under 'Acute Kidney Injury Due to Volume Depletion'. FDA also recorded that sufficient risk mitigation approaches could not be identified, 'particularly because serious AKI events occurred in participants who received ITCA 650 who did not have known risk factors'. SCOPE: this is a finding about ITCA 650, an implanted continuous-delivery product FDA refused to approve. It is not a finding about the approved injection, whose renal risk is handled by a labeled warning rather than a refusal.

  Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650 (89 FR 68168) — FDA, 23 August 2024

  “a majority of the serious AKI events in participants randomized to ITCA 650 appeared to be associated with vomiting, diarrhea, and dehydration, which are known adverse reactions associated with exenatide therapy, supporting a causal relationship between ITCA 650 and AKI”

  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.

Is Byetta still available in 2026?

No. FDA withdrew approval of Byetta (NDA 021773) effective 3 September 2025. The Federal Register notice states that the applicants 'have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c))', and that they waived their opportunity for a hearing. The same notice withdrew approval of Bydureon and Bydureon Pen (NDA 022200) and Bydureon BCise (NDA 209210). This is stronger than a discontinuation: FDA states that introducing a product listed in that table into interstate commerce without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act, though inventory on hand at the effective date could continue to be dispensed until depleted or expired. Exenatide itself is still available as an approved drug — a generic exenatide injection under ANDA 206697 (Amneal Pharmaceuticals) is what remains.

Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications (90 FR 36440) — FDA, 4 August 2025

“Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of September 3, 2025.”

Checked against the source on 2 August 2026.

Is exenatide approved for weight loss?

No. The FDA-approved labeling for the marketed exenatide product carries exactly one indication: 'Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.' There is no weight management indication, no cardiovascular risk-reduction indication and no obesity indication. That is true of every exenatide label, not just the current one — the final Byetta label and the last Bydureon BCise label each carry the glycemic indication and nothing else. Exenatide therefore does not follow the rest of the GLP-1 class, several members of which do hold weight-management approvals. Prescribing exenatide for weight loss is off-label use, which is a decision for a licensed prescriber and is not something this label supports.

EXENATIDE injection, for subcutaneous use — Prescribing Information (SPL, ANDA 206697) — FDA, 27 May 2026

“Exenatide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”

Checked against the source on 2 August 2026.

Why was Bydureon discontinued?

The primary document gives one stated reason and no other: the products were no longer marketed. FDA's Federal Register notice records that the applicants 'informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c)'. Approval of Bydureon and Bydureon Pen (NDA 022200) and of Bydureon BCise (NDA 209210) was withdrawn effective 3 September 2025. Read that carefully in both directions. The notice records no FDA determination that the products were unsafe or ineffective — but a withdrawal made at the sponsor's request is the absence of a finding, not an endorsement, and the notice does not say the products were withdrawn for reasons other than safety either. FDA also states this kind of withdrawal is 'without prejudice to refiling'. One further oddity worth knowing if you cite a date: both Bydureon applications appear a second time in a later FDA notice withdrawing approval as of 8 April 2026.

Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications (90 FR 36440) — FDA, 4 August 2025

“The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling.”

Checked against the source on 2 August 2026.

Can you still get exenatide if Byetta and Bydureon are gone?

Yes — as a generic. Drugs@FDA lists exenatide injection under ANDA 206697 (Amneal Pharmaceuticals), approved 19 November 2024, with marketing status 'Prescription', therapeutic equivalence code AP, and both of its products flagged as reference standard. FDA hosts a current approved label for it with an SPL effective date of 27 May 2026. Note the chronology, because it is unusual: FDA approved the generic nine months before the brand it references lost its approval, and Drugs@FDA now flags the generic as the reference standard — the role the originator used to hold. Only the immediate-release injection survives; there is no marketed extended-release exenatide product, so the once-weekly presentation and the paediatric indication that came with it both left the market with Bydureon.

Drugs@FDA — applications containing exenatide (openFDA drug/drugsfda) — FDA, 31 July 2026Checked against the source on 2 August 2026.

Does exenatide have a boxed warning for thyroid cancer?

It depends entirely on which exenatide product you mean, and the answer flipped when the brands were withdrawn. The extended-release products carried a boxed warning: 'Exenatide extended-release causes an increased incidence in thyroid C-cell tumors at clinically relevant exposures in rats compared to controls. It is unknown whether BYDUREON BCISE causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans...' — together with a contraindication in patients with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2. Those applications had their approvals withdrawn effective 3 September 2025. The immediate-release exenatide injection that remains on the market carries no boxed warning at all and no MTC or MEN 2 contraindication. Its labeling does still report, in the nonclinical toxicology section, that benign thyroid C-cell adenomas were observed in female rats in a 104-week carcinogenicity study. Same active ingredient, different formulation, different highest-level FDA warning — so a claim about 'exenatide' that does not name the product cannot be checked.

BYDUREON BCISE (exenatide) extended-release injectable suspension — Highlights of Prescribing Information (NDA 209210, SUPPL-25) — FDA, 28 May 2025

“WARNING: RISK OF THYROID C-CELL TUMORS … BYDUREON BCISE is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).”

Checked against the source on 2 August 2026.

Did FDA ever approve an exenatide implant?

No. FDA issued an order refusing to approve NDA 209053 for ITCA 650 (exenatide in DUROS device), an osmotic mini-pump implanted in the subdermal space that was proposed for the same indication as the injection — as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA concluded that 'Intarcia has not demonstrated that ITCA 650 is safe for its intended use' and denied approval. The grounds recorded in FDA's decision include acute kidney injury events occurring more often on ITCA 650 than on placebo, an unresolved cardiovascular risk signal, and drug-delivery variability that FDA found 'compare unfavorably to approved products with a similar or identical active ingredient'. This was a full adjudicated refusal after a hearing request, not a complete response letter — the notice is dated 23 August 2024, following an NDA first submitted in November 2016.

Final Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650 (89 FR 68168) — FDA, 23 August 2024

“FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.”

Checked against the source on 2 August 2026.