Alembic Gets ANDA Nod for Bupropion Hydrochloride Tab  | CORPORATE ETHOS

Alembic Gets ANDA Nod for Bupropion Hydrochloride Tab 

By: | June 11, 2018
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Jun 11: Drug maker Alembic Pharmaceuticals Ltd on Monday announced 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.

According to the company, 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, it said.

Bupropion Hydrochloride Tablets USP, 75 mg and 100 mg, have an estimated market size of $ 37 million for twelve months ending December 2017 according to IMS.

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