Strides Pharma introduced on Tuesday that its Singapore-based subsidiary, Strides Pharma International Pte, has acquired USFDA approval for Levetiracetam Oral Answer USP, 100 mg/mL. This generic treatment is taken after the onset of partial seizures. The product is bioequivalent and therapeutically equal to the Reference Listed Drug (RLD), Keppra Oral Answer, 100 mg/mL, from UCB, Inc.
The product can be manufactured on the firm’s facility in Bengaluru. In response to the US Nationwide Institutes of Well being, levetiracetam is an oral prescription treatment used to deal with partial seizures in folks with epilepsy aged 4 years and older. It’s also used for myoclonic seizures (transient, non-cyclic) in folks aged 12 years and older who’ve juvenile myoclonic epilepsy.
The Levetiracetam Oral Answer market dimension is roughly $55 million, in keeping with knowledge reported by IQVIA.
Strides Pharma already has 260 cumulative Abbreviated New Drug Purposes (ANDAs) filed with the FDA, of which 230 have been authorised.
Strides has additionally set a objective to launch 60 new merchandise over three years in the US, in keeping with an organization assertion.
On Tuesday, Strides Pharma shares rose 0.85 per cent, ending the day’s buying and selling at Rs 494.50 per share on the BSE.
First printed: November 21, 2023 | 4:50 pm he
(Tags for translation)USFDA