Strides Pharma Science announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved.
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