Mumbai, Oct 20 (PTI) Strides Pharma Science (Strides) Saturday announced that its global arm Strides Pharma Global Pte Singapore has received USFDA approval for Gabapentin Capsules.
Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer Inc, a release said here.
It’s an anticonvulsant or antiepileptic drug used with other medication to prevent and control seizures and also used to relieve nerve pain following shingles in adults.
Strides Pharma Global Pte Singapore received approval for Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg from the United States Food and Drug Administration (USFDA).
The product received approval in the first cycle of review of 10 months under the GDUFA II regime.
The product will be marketed by Strides Pharma Inc in the US market.
The company has 78 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 53 ANDAs have been approved and 25 are pending approval.
This is published unedited from the PTI feed.