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Corporate - Standards & Benchmarks


Ranbaxy gets tentative nod from USFDA for Modafinil

Our Bureau

New Delhi , Feb. 23

RANBAXY Laboratories Ltd has received a tentative approval from the US Food and Drug Administration, (USFDA) Office of Generic Drugs, to manufacture and market Modafinil tablets in 100 mg and 200 mg units.

Modafinil helps improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Ranbaxy Pharmaceuticals Inc (RPI), a wholly-owned subsidiary, would support the sales and marketing of the product. The total market for Modafinil tablets last year stood at $297 million.

The product will be made available to all pharmacy outlets located throughout the US including chain and independent pharmacies, wholesalers, and generic distributors at the time final approval is granted by the USFDA.

"When approved, this product will provide a central nervous system (CNS) product to RPI's expanding product portfolio, along with our commitment to bring affordable generic alternatives to the US healthcare system," said Mr Jim Meehan, Vice-President (Sales and Marketing), RPI.

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