Strides Pharma gets USFDA nod for generic medication
Strides Pharma Science on Tuesday said its subsidiary has received approval from the US health regulator to market a generic medication for seizures.
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Strides Pharma Science on Tuesday said its subsidiary has received approval from the US health regulator to market a generic medication for seizures.
Singapore-based Strides Pharma Global Pte Ltd has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the US Food & Drug Administration (USFDA), the company said in a regulatory filing.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Keppra Oral Solution of UCB, Inc, it added.
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It is used in the treatment of seizures.
As per IQVIA data, the Levetiracetam Oral Solution has a market size of USD 55 million.
The product will be manufactured at the company's facility in Bengaluru, the drug firm said.
The company said it now has 260 cumulative abbreviated new drug application (ANDA) filings with the USFDA, of which over 230 filings have been approved.
The company said it has set a target to launch 60 new products over three years in the US.
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