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Conditional OK for Cephalon Drug

10/21/05 - 03:55 PM EDT

TSC Staff

Cephalon (CEPH - Cramer's Take - Stockpickr) received conditional approval from regulators for Sparlon, a treatment for attention deficit hyperactivity disorder that has the same active ingredient as the company's Provigil.

The Frazer, Pa., company got what's called an approvable letter from the Food and Drug Administration. Still, that doesn't allow Cephalon to start selling Sparlon just yet.

The biopharmaceutical firm will have to meet some kind of additional requirement before it can receive full marketing clearance, but Cephalon didn't provide details about what conditions the FDA attached to the approval.

Sparlon, which had been known as Attenace previously, is designed for ADHD in children and adolescents aged 6 through 17. The company said it was "working closely with the FDA to obtain final approval" for the drug.

Cephalon expects to launch Sparlon in early 2006 if it gets the regulatory green light. Shares of Cephalon were gaining 98 cents, or 2.2%, to $45.26.

Provigil is approved for adults with excessive sleepiness associated with narcolepsy, sleep apnea and a sleep disorder related to shift work.


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