Alembic Pharmaceuticals has secured multiple approvals from the US Food and Drug Administration (USFDA), further strengthening its generics portfolio in the US market.
The company on Friday (June 26) received final approval for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%, a generic version of Aczone Gel, 5% by Almirall. Dapsone Gel is indicated for the topical treatment of acne vulgaris.
This marks the second acne vulgaris treatment approved for Alembic by the USFDA this month. Earlier, on June 12, the company received approval for Tretinoin Cream USP, 0.05%, which is therapeutically equivalent to Retin-A Cream, 0.05% of Bausch Health US. The product is also indicated for topical application in the treatment of acne vulgaris.
Separately, the USFDA has approved Alembic’s ANDA for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, the generic equivalent of Tamiflu Oral Suspension, 6 mg/mL from Hoffmann-La Roche.
Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for the treatment of acute, uncomplicated influenza A and B in patients aged two weeks and older who have shown symptoms for no more than 48 hours. It is also approved for the prophylaxis of influenza A and B in patients aged one year and above.
With these approvals, Alembic’s cumulative USFDA ANDA tally has reached 244 approvals, comprising 224 final approvals and 20 tentative approvals.
Earlier, on June 19, the company received tentative approval for its ANDA for Binimetinib Tablets, 45 mg, having previously secured tentative approval for the 15 mg strength. The product is therapeutically equivalent to Mektovi Tablets of Array.
Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations, as well as adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
According to the FDA’s Paragraph IV Certifications List, Alembic is the sole first applicant to file an ANDA for Binimetinib Tablets, 45 mg, with a Paragraph IV certification under the Hatch-Waxman Act. Subject to final USFDA approval, the company may qualify for 180 days of generic marketing exclusivity in the US.
