Alembic has received the Food and Drug Administration’s approval for solifenacin succinate tablets, in 5-mg and 10-mg dosage strengths.
The product is indicated for the treatment of overactive bladder.
It is the generic of Astellas Pharma’s Vesicare tablets.
Solifenacin succinate tablets 5 mg and 10 mg had a market value of approximately $967 million for the 12 months ending December 2018, according to IQVIA.