Semaglutide ANDA 220314 Tentative Approval, Apotex
Summary
FDA has issued a Tentative Approval for ANDA #220314 filed by Apotex Inc., covering five semaglutide injection formulations in varying strengths (2.68 mg/mL, 2 mg/1.5 mL, 2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL). Tentative Approval indicates the application meets FDA requirements for safety, efficacy, and quality, but marketing cannot begin because of existing patent or exclusivity protections on the reference listed drug. No Marketing Status, TE Code, RLD, or RS designation has been assigned.
About this source
GovPing monitors FDA Drugs@FDA - New Applications and Actions for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
FDA issued a Tentative Approval to Apotex Inc. for Abbreviated New Drug Application (ANDA) #220314, covering five semaglutide injection formulations. The approval covers all five listed strength variants, each showing Marketing Status as 'None (Tentative Approval)' with no TE Code, RLD, or RS designation. Tentative Approval is distinct from full approval: the application has met FDA's scientific and regulatory standards, but federal law prevents the agency from granting full approval and permitting marketing while valid patents or exclusivity protections remain in effect for the reference listed drug.
Manufacturers monitoring the generic pipeline should note that tentative approvals represent a near-term market-entry signal — Apotex is positioned to launch immediately upon expiration of applicable patent or exclusivity protections. Competing generic applicants and branded drug sponsors should track the RLD's patent calendar accordingly. Healthcare providers and payers may anticipate future cost-competition for these semaglutide formulations pending final approval.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Abbreviated New Drug Application (ANDA): 220314
Company: APOTEX INC
- Email
Products on ANDA 220314
CSV Excel Print
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| SEMAGLUTIDE | SEMAGLUTIDE | 2.68MG/1ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| SEMAGLUTIDE | SEMAGLUTIDE | 8MG/3ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| SEMAGLUTIDE | SEMAGLUTIDE | 4MG/3ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| SEMAGLUTIDE | SEMAGLUTIDE | 2MG/1.5ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| SEMAGLUTIDE | SEMAGLUTIDE | 2MG/3ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
Showing 1 to 5 of 5 entries
Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220314
Parties
Related changes
Get daily alerts for FDA Drugs@FDA - New Applications and Actions
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA Drugs@FDA - New Applications and Actions publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.