| Strides Pharma Science (Strides) today announced that its
step]down wholly owned subsidiary, Strides Pharma Global, 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 Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA. The product will be manufactured at the companyfs facility in Bengaluru.
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. The company has set a target to
launch ~ 60 new products over three years in the US. |