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FDA Wants More Telavancin Safety, Efficacy Data

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FDA asks Theravance to submit additional data and analyses for use in evaluating the safety and efficacy of its telavancin for tre...

Appeals Court Rules Against Generic Drug Makers

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A federal appeals court reverses a lower court decision, finding that state failure-to-warn claims against generic manufacturers o...

FDA Approves New Cymbalta Indication

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FDA approves Lillys Cymbalta for a new indication maintenance treatment of generalized anxiety disorder in adults.

Animal Drug Sponsor Changed to Schering-Plough

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Federal Register Final rule: FDA amends the animal drug regulations to reflect a change of sponsor for 29 NADAs for 2 ANADAs to Sc...

IT Advances Not Speeding Drug Approvals: Study

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East Carolina University researchers say that FDAs new information technology systems has not cut the time needed to review NDAs.

FDA Clarifies Labeling Requirements for OTC Pain Drugs

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Federal Register Final rule: FDA amends a final rule on labeling for OTC internal analgesic, antipyretic, and antirheumatic drug p...

Guidance on Residual Solvents in Drugs

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Federal Register Notice: FDA releases a guidance, Residual Solvents in Drug Products Marketed in the U.S.

FDA Approves Intelence

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FDA gives traditional approval to Tibotecs Intelence for treating HIV-1 infection in certain patients.

FDA Accepts NDA for Aricept ER Formulation

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FDA accepts for review an Eisai NDA for once-daily 23 mg Aricept (donepezil HCl) extended-release tablets for treating moderate to...

Zalbin BLA Submitted

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Human Genome Sciences submits a BLA to FDA for Zalbin to treat hepatitis C.