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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 7th July 2012, 08:16 AM
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Default Cymbalta Pediatric Trial "Inconclusive" But Gets 6-Month U.S. Market Extension Anyway

Source: WSJ

Lilly Gets Exclusivity Extension for Cymbalta

By PETER LOFTUS

Eli Lilly & Co. said Friday its blockbuster antidepressant Cymbalta will have an additional six months of U.S. market exclusivity—through December 2013—because the company studied the drug's effects on children.

Lilly said, however, that it won't seek regulatory approval to market Cymbalta for pediatric use because study results were inconclusive regarding Cymbalta's efficacy in children.

The U.S. market exclusivity for Cymbalta will now expire in December 2013; it was previously due to expire in June 2013, in accordance with the drug's patent. Generic copies of the drug can be introduced after market exclusivity expires.

The U.S. Food and Drug Administration can grant an additional six months of market exclusivity as an inducement for companies to study the efficacy and safety of drugs in children. Lilly said Friday it has met the FDA requirements for pediatric exclusivity for Cymbalta.

Cymbalta is approved by the FDA to treat depression, generalized anxiety disorder and certain pain conditions in adults. The drug's prescribing label carries a prominent warning that antidepressants could increase the risk of suicidal thinking and behavior in children, adolescents and young adults, and that Cymbalta isn't approved for use in pediatric patients.

Lilly conducted two studies of Cymbalta in children and adolescents, according to spokeswoman Sonja Popp-Stahly. The studies found that neither Cymbalta nor another antidepressant, fluoxetine, were shown to be better than placebos in treating pediatric depression.

In April, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion.

The company is grappling with a number of patent expirations for top-selling drugs, including its antipsychotic Zyprexa last October. It is working to fill its pipeline through acquisitions, its own research labs and by collaborating with several other major drug makers.

—Saabira Chaudhuri contributed to this article.
Write to Peter Loftus at peter.loftus@dowjones.com
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