FDA Approves SOLRIAMFETOL HYDROCHLORIDE — ORIG Submission by ALKEM LABS LTD, Not disclosed in the FDA record.

Key facts

Regulatory context

This application was reviewed under FDA's standard review pathway, which typically targets a 10-month review goal measured from submission. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements.

What was approved

FDA's record shows ALKEM LABS LTD as the sponsor of SOLRIAMFETOL HYDROCHLORIDE, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. This specific application is submission type ORIG (submission number 1) under application number ANDA218722, with a submission status date of 20260617. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

ALKEM LABS LTD’s FDA history

Argus HQ has recorded 1 total FDA action tied to ALKEM LABS LTD: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

What did FDA approve?

FDA's record shows ANDA approval for SOLRIAMFETOL HYDROCHLORIDE (Not disclosed in the FDA record.), dosage form TABLET, sponsored by ALKEM LABS LTD, under application number ANDA218722. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

What does the submission type mean?

An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards.

Is this product available now?

FDA's record lists a submission status date of 20260617. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

Does ALKEM LABS LTD have other FDA approval records?

This is the only FDA action Argus HQ has on file for ALKEM LABS LTD so far. Argus ingests new FDA records daily.

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