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

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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.

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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 %

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.

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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.

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