Alembic gets FDA green light for generic Viibryd; tentative nod for generic Jardiance
The Food and Drug Administration has approved two Alembic generics, one tentatively.
The company has received full approval for its generic of Allergan's Viibryd (vilazodone hydrochloride tablets). The generic was approved in dosage strengths of 10 mg, 20 mg, and 40 mg, and is indicated for the treatment of major depressive disorder.
Vilazodone hydrochloride tablets had a market value of $469 million for the 12 months ended September 2019, according to IQVIA.
The FDA gave tentative approval to Alembic’s generic of Boehringer Ingelheim's Jardiance *(empagliflozin tablets). The drug, which is indicated for glycemic control in patients with Type 2 diabetes along with diet and exercise, was approved in dosage strengths of 10 mg and 25 mg.
The product had a market value of roughly $3.4 billion for the 12 months ended September 2019, according to IQVIA.