Alembic Pharmaceuticals gets FDA approval for Metronidazole Gel USP, 1 %

Alembic Pharmaceuticals said that its joint venture – Aleor Dermaceuticals has secured tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Metronidazole Gel USP, 1 %.

According to the Indian pharma company, the approved ANDA is equivalent therapeutically to the reference listed drug product (RLD) – Metrogel Gel, 1 %, owned by Galderma Laboratories.

Metronidazole Gel USP, 1 % has approval in the US for the topical treatment of inflammatory lesions of rosacea.

Alembic Pharmaceuticals gets FDA approval for Metronidazole Gel USP, 1 %

Citing IQVIA, Alembic Pharmaceuticals said that Metronidazole Gel USP, 1 % had an estimated market size of $32 million for 12 months ending December 2020.

Alembic Pharmaceuticals has a total of 142 ANDA approvals, which include 124 final approvals and 18 tentative approvals from the FDA.

Last month, the Indian pharma company secured final approval from the FDA for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.