Ranbaxy Laboratories Ltd. (RLL) has received final
approval for manufacturing and marketing multiple doses of Gabapentin
capsules. The approval permits RLL to manufacture and market the
medicine in multiple doses of 100 mg, 300 mg and 400 mg, the company
informed the Bombay Stock Exchange on Monday.
The Office of Generic
Drugs, found Ranbaxy's formulations to be bioequivalent, having
the same therapeutic effect as that of the reference listed drug,
Pfizer's Neurontin Capsules. Gabapentin is indicated for the management
of postherpetic neuralgia in adults.
The medicine is also indicated as adjunctive therapy
in the treatment of partial seizures with and without secondary
generalization in epilepsy patients aged 12 and above.
It treats partial seizures in pediatric patients aged between 3-12
years as well.
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