Alembic Pharmaceuticals Limited has received final approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vardenafil Hydrochloride tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Levitra tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, of Bayer Healthcare Pharmaceuticals Inc. According to IQVIA, Vardenafil Hydrochloride tablets have an estimated market size of USD 35 million for twelve months ending June 2020.
Vardenafil Hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Last month, the company had got tentative approval from USFDA for its ANDA, Empagliflozin and Metformin Hydrochloride tablets, 5 mg/500 mg, 5 mg/1,000 mg, 12.5 mg/500 mg, and 12.5 mg/1,000 mg used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Alembic now has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from USFDA. For the quarter ending June 2020, the company’s international formulations business grew 70 per cent YoY and ex-US international formulations grew 62 per cent YoY. Its US generics business grew 73 per cent YoY during the quarter.
On Wednesday, during the early morning session, the stock of Alembic Pharma was up by 1.5 per cent at Rs 1,032.55 from its previous close of Rs 1,017.15 on BSE.