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Alembic Pharma gets final approval from USFDA for OCD treatment drug

The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clomipramine Hydrochloride Capsules USP in the strengths 25 mg, 50 mg, and 75 mg, Alembic Pharmaceuticals said in a regulatory filing.

August 05, 2021 / 02:14 PM IST
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Drug firm Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Clomipramine Hydrochloride capsules, used for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).

The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clomipramine Hydrochloride Capsules USP in the strengths 25 mg, 50 mg, and 75 mg, Alembic Pharmaceuticals said in a regulatory filing.

The approved product is therapeutically equivalent to the reference-listed drug product Anafranil Capsules of SpecGX LLC.

Clomipramine Hydrochloride Capsules are indicated for the treatment of obsessions and compulsions in patients with OCD.

Quoting IQVIA data, Clomipramine Hydrochloride Capsules USP 25 mg, 50 mg, and 75 mg have an estimated market size of $32 million for twelve months ending June 2021.

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Alembic has a cumulative total of 149 abbreviated new drug application (ANDA) approvals, which includes 131 final approvals and 18 tentative approvals, from USFDA.
PTI
first published: Aug 5, 2021 02:14 pm

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