Ranbaxy’s Deneric Provigil Gets Tentative FDA Nod

Tomas Thorne

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Last Updated: February 2, 2023

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BOMBAY (Reuters) – Drugmaker Ranbaxy Laboratories Ltd has got tentative approval for Modafinil tablets, a generic form of narcolepsy drug Provigil, the U.S. Food and Drug Administration (FDA) said late Thursday.

Provigil, the flagship drug of Cephalon Inc., is prescribed for a rare disorder marked by uncontrollable sleep during normal waking hours.

The drug targets a part of the brain that controls sleep and waking, but researchers do not know exactly how it works.

West Chester, Pennsylvania-based Cephalon last month also got approval to market Provigil to truck drivers and others whose work shifts make it difficult to stay awake on the job.

Ranbaxy, India’s top drug maker by sales, is the second firm to receive tentative approval from the U.S. FDA for generic Provigil after Barr Pharmaceuticals Inc. got clearance last month.

The approval is for 100 and 200 mg tablets.

Cephalon has forecast sales of $375 million to $425 million for Provigil in 2004.

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