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FDA Looking at Skin Reactions to Epilepsy Drugs

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FDA is looking into a potential increased risk of serious skin reactions in some Asian patients taking phenytoin or fosphenytoin t...

Kindness Debarred

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Federal Register Notice: FDA issues an order to permanently debar George Kindness from providing services to anyone with an approv...

FDA Approves Tapendatol for Pain Relief

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FDA approves Johnson & Johnsons new moderate-to-severe pain reliever tapendatol immediate release tablets.

FDA Extends Silenor Review

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FDA extends by 90 days the PDUFA deadline for its review of Somaxons NDA for Silenor to treat insomnia.

FDA Orphan Drug Designation for Hemophilia Therapy

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FDA grants an orphan drug designation to Biovitrum AB and Syntonix Pharmaceuticals for their FIXFc compound, indicated for treatin...

Protherics Opens Rolling Voraxaze BLA

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Protherics submits to FDA the first element of its rolling BLA for Voraxaze, an agent to mitigate methotrexate toxicity.

Genzyme Seeks New Leukemia Use for Clolar

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Genzyme Corp. submits a supplemental NDA for Clolar (clofarabine) seeking approval in treating adult patients with acute myeloid l...

FDA Accepts Filing of Dyax BLA

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FDA has accepted for filing Dyax BLA for its DX-88 to treat acute hereditary angioedema attacks.

CSL Behring Field Correction

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CSL Behring initiates a field correction on five lots of its Component Pack packaged with Mononine (Coagulation Factor IX, Human).

Comments Sought on Rx Effectiveness

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Federal Register Notice: FDA seeks comments on a proposed collection of information on how health care providers understand prescr...