Source: Reuters
Date: 20 February 2004

Ranbaxy's generic Provigil
gets tentative FDA nod

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.
further reading

Product Info
Barr modafinil
Caphalon, Inc
BLTC Research
The Good Drug Guide
Teva Pharmaceuticals
Modafinil (Provigil) : structure
Modafinil: The Kelli White Affair
Modafinil (Provigil) and Beyond
Big Pharma and Madison Avenue
Modafinil (Provigil): FDA endorses new uses