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Sunovion Plans to Resubmit Epilepsy NDA

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Sunovion Pharmaceuticals (formerly Sepracor) says it will resubmit next year its NDA for Stedesa (eslicarbazepine acetate), indica...

Use Restrictions on Drug Promo Launch Materials Under Review

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FDA says drug marketers should not use the same or similar claims contained in voluntarily submitted product launch advertising an...

New Critical Path Institute Head Known Soon

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Retiring Critical Path Institute director Raymond Woosley says his successor should be announced by next month.

Genentech Agrees to Pay $20 Million in Whistleblower Suit

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Genentech agrees to pay $20 million to settle claims in a whistleblower lawsuit that alleges the company promoted Rituxan (rituxim...

FDA Lipitor Petition Denial Posted

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FDA posts a petition rejection letter dismissing Pfizer attempts to delay the introduction of generic Lipitor (atorvastatin) produ...

FDA OKs Mylan ANDA for Hemophilia

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FDA approves a Mylan ANDA for tranexamic acid injection, a generic version of Pharmacia & Upjohns Cycklokapron injection, indicate...

Woodcock: Coming of Age for Speedier Drugs Consortia

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CDER director Janet Woodcock says we have reached a coming of age for the multiple consortia around the world working on different...

FDA Orders Dietary Supplement Product Seizures

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At FDAs request, U.S. marshals seize all dietary supplements made by Hillsboro, WI-based Syntec over alleged false claims made abo...

Generic Mfg. Supplement Backlogs a Cause of Shortages: Gottlieb

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Former FDA deputy commissioner Scott Gottlieb tells Congress that delays as long as several years in FDA approval of almost 3,000 ...

Hamburg: Regulatory Science Undervalued

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Commissioner Margaret Hamburg says she fears the field of regulatory science remains undervalued and underdeveloped as an importan...