Merck NDA 216964 IDVYNSOTM Doravirine Islatravir Combo Approved
Summary
The FDA approved New Drug Application (NDA) 216964 filed by Merck Sharp and Dohme LLC for IDVYNSOTM, a fixed-dose combination product containing Doravirine (100MG) and Islatravir (0.25MG) in tablet form for oral administration. The product received Prescription marketing status, making it available for clinical use. This approval represents a new antiretroviral combination therapy option for patients requiring HIV treatment.
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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
The FDA approved NDA 216964 for IDVYNSOTM, a fixed-dose combination of Doravirine (100MG) and Islatravir (0.25MG) in an oral tablet dosage form submitted by Merck Sharp and Dohme LLC. The product is classified as Prescription medication with no assigned TE Code and is not designated as RLD or RS.
Pharmaceutical companies developing or marketing antiretroviral therapies should monitor this approval as it introduces a new combination therapy option in the HIV treatment landscape. Merck must comply with ongoing FDA post-market obligations, including adverse event reporting and periodic safety updates as required under the FD&C Act.
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.
New Drug Application (NDA): 216964
Company: MERCK SHARP AND DOHME LLC
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Products on NDA 216964
CSV Excel Print
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
| --- | --- | --- | --- | --- | --- | --- | --- |
| IDVYNSOTM | DORAVIRINE AND ISLATRAVIR | 100MG/0.25MG | TABLET; ORAL | Prescription | None | No | No |
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Approval Date(s) and History, Letters, Labels, Reviews for NDA 216964
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