FDA approves Alembic’s generic drug for Major Depressive Disorder

Alembic Pharmaceuticals, a vertically integrated Research and Development Pharmaceutical company, announced on June 11^th 2018, that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Wellbutrin Tablets, 75 mg and 100 mg, of GlaxoSmithKline LLC. Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg is indicated for the treatment of Major Depressive Disorder.

As per the company, Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg, have an estimated market size of US$ 37 million for twelve months ending December 2017 as per IMS.

Alembic now has a total of 72 ANDA approvals (64 final approvals and 8 tentative approvals) from USFDA.

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News Source: Alembic Pharmaceuticals website

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