Mumbai, June 13, 2018: Pharma major, Alembic Pharmaceuticals has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride tablets USP 75 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Wellbutrin tablets of GlaxoSmithKline LLC.
Bupropion Hydrochloride tablets USP 75 mg and 100 mg is indicated for the treatment of major depressive disorder.
Bupropion Hydrochloride tablets USP 75 mg and 100 mg have an estimated market size of USD37 million for 12 months ending December 2017 according to IMS.
The company now has 72 ANDA approvals from the USFDA.
United News of India
