GILEAD SCIENCES INC: manufacturing (CMC) supplement approved for BIKTARVY
GILEAD SCIENCES INC: manufacturing (CMC) supplement approved for BIKTARVY. Dated 167 days ago, it serves as a historical benchmark. Score 40/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | GILEAD SCIENCES INC |
| Product | BIKTARVY |
| Generic / ingredient | BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE |
| Approval | Drug manufacturing (CMC) supplement |
| Application | NDA210251 supplement 26 |
| Decided | 2026-05-21 |
| Panel / class | TABLET, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-05-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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40 / 100 Score
- Manufacturing change: sites, suppliers or process.
What is the FdaApprovalPulse record for GILEAD SCIENCES INC?
The FDA approved BIKTARVY (NDA210251 supplement 26) for GILEAD SCIENCES INC on 2026-05-21: drug manufacturing (CMC) supplement.
How does GILEAD SCIENCES INC compare to other FdaApprovalPulse records?
It is 167 days old; check the official source for later updates before acting.
GILEAD SCIENCES INC vs. top 3 peers
| Organization | Record date |
|---|---|
| GILEAD SCIENCES INC | 2026-05-21 |
| BIOCON BIOLOGICS INC | 2026-10-22 |
| ALKEM LABS LTD | 2026-10-21 |
| ACTAVIS LABS FL INC | 2026-10-19 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.