Banglore: Strides Pharmaceutical Science’s step-down wholly-own 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 following shingles, in adults.
The product will be marketed by Strides Pharma in the US market.
The company has 78 cumulative ANDA (abbreviated new drug application) filings with US FDA, of which 53 have been approved and 25 are pending approval. Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.