Wednesday, 14 November 2018

Strides Pharma gets USFDA nod for its anti-epileptic drug

22 October 2018 | News

The drug will be available in three doses of 100 mg, 300 mg, and 400 mg

Strides Pharma Science (Strides) on 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.

 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 Stride Pharma in the US market.

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