Marksans Pharma receives USFDA approval for Pregabalin Capsules; Stock surges 2%

21 Jul 2022 , 02:45 PM

Marksans Pharma Limited has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg and 225 mg, 300 mg.

According to the regulatory filing released on Thursday, the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg and 225 mg, 300 mg, of Upjohn US 2 LLC.

In US, Pregabalin capsules (RLD Lyrica) had estimated annual sales of $263 million. (IQVIA MAT March 2022).

At around 2:45 PM, Marksans Pharma was trading at Rs50.30 per share up by Rs1.05 or 2.13% from its previous closing of Rs49.25 per share on the BSE.