December 5, 2008
 

FDA Approves New Drug to Treat Severe Form of Epilepsy


FDA Approves New Drug to Treat Severe Form of Epilepsy
The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
(UPDATE) FDA issued Q and As for recently approved Medication Guides.

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
See Web site for additional information.

Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel
Voluntary recall due to samples of the products containing Burkholderia Cepacia bacteria.

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