Strides Pharma Science’s step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval
for Gabapentin capsules from the United States Food & Drug Administration (US FDA). The product received approval in the first cycle of review of 10 months under the GDUFA II regime.
The drug will be available in three doses of 100 mg, 300 mg, and 400 mg. The US market for these three doses is $270 million.
The medicine is a generic version of Neurontin capsules of Pfizer, and is an antiepileptic drug used with other medications to prevent and control seizures. It is also used to relieve nerve pain