Strides Pharma gets USFDA approval for Levetiracetam Oral Solution

Strides Pharma on Tuesday announced that its wholly-owned Singapore-based subsidiary, Strides Pharma Global Pte, has received approval from the United States Food and Drug Administration (USFDA) for Levetiracetam Oral Solution USP, 100 mg/mL. This generic drug is taken after the partial onset of seizures. The product is deemed bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL, of UCB, Inc.

The product will be manufactured at the company’s facility in Bengaluru. According to the US National Institute of Health, Levetiracetam is a prescription-based drug, taken orally, that is used to treat partial onset seizures in people aged 4 years and older with epilepsy. It is also used for myoclonic (brief and acyclic) seizures in people aged 12 years and older with juvenile myoclonic epilepsy.

The Levetiracetam Oral Solution has a market size of around $55 million, according to data reported by IQVIA.

Strides Pharma already has 260 cumulative Abbreviated New Drug Applications (ANDAs) filed with the USFDA, of which 230 have been approved.

Strides has also set a target to launch 60 new products over three years in the US, according to the company's statement.

On Tuesday, shares of Strides Pharma were up by 0.85 per cent, ending the day's trade at Rs 494.50 apiece on the BSE.