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Mylan Generic Serafem Tentatively OKd

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FDA tentatively approves Mylans generic form of Lillys Serafem capsules for treating premenstrual dysphoric disorder.

Texas Court Narrows Compounded Drugs Exemption

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A federal judge in Texas narrows his earlier bench ruling on compounded drugs, saying that only reasonable quantities of compounde...

Settlement Brings Scherings Penalties Past $1 Billion

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Consulting editor John Scharmann calculates that Schering-Ploughs latest settlement with the government brings to over $1 billion ...

Advisors Recommend Gestiva Approval

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FDAs Reproductive Health Drugs Advisory Committee recommends the agency approve Adezas Gestiva for preventing pre-term birth.

FDA Warns on Counterfeit Drugs from Canada

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FDA issues a counterfeit drug warning to consumers advising them not to purchase prescription drugs from certain Canadian-operated...

CHPA Favors Two-Class Drug Distribution

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The nonprescription drug industrys trade association, CHPA, says it opposes a three-class drug distribution system that would redu...

Human Tissue Task Force Formed by FDA

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FDA announces a multidisciplinary task force to review the effectiveness of human tissue regulations promulgated last year.

Reformulated Drugs Shouldnt Look the Same

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FDA Webview Washington commentator Robert Steeves says reformulated OTC drug products like Sudafed PE should be given a different ...

Cardinal Health Suspends Alaris Pump Production

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Cardinal Health suspends production, sales, repairs, and installations of its seized Alaris SE infusion pump.

FDA Will Review Zensana Oral Spray

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FDA says it will review Hana Biosciences NDA for an oral spray version of ondansetron, indicated for preventing nausea and vomitin...