Comments
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.
Also read: Alembic Pharma bags USFDA final nod for orthostatic hypotension tablets
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 USP25 mg, 50 mg, and 75 mg have an estimated market size of USD 32 million for twelve months ending June 2021.
Alembic has a cumulative total of 149 abbreviated new drug application (ANDA) approvals, which includes 131 final approvals and 18 tentative approvals, from USFDA.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.