Strides Pharma rallies after seizure drug receives US FDA approval

Shares of Strides Pharma Science Limited traded 2.68 percent up at Rs 503.70 around 11.17am on the NSE on November 21 after its seizures drug received the US Food & Drug Administration (USFDA) green light.

The company's wholly owned step-down subsidiary, Strides Pharma Global Pte Limited, Singapore, has received the approval.

Levetiracetam Oral Solution USP, 100 mg/mL is bioequivalent and therapeutic equivalent to the Referene Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc.The Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA.

The product will be manufactured at the company’s facility in Bengaluru. Strides Pharma has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.