“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,” Alembic Pharma said in a press release.
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 are indicated for the treatment of major depressive disorder.
According to IMS, Bupropion hydrochloride tablets USP, 75 mg and 100 mg, have an estimated market size of US$ 37 million for twelve months ending December 2017.
Alembic Pharma said it has now a total of 72 ANDA approvals (64 final approvals and 8 tentative approvals) from USFDA.