Allergan announced FDA approval of its Juvederm gel family of products, hyaluronic acid dermal fillers that provide correction of facial wrinkles and folds.
BioMarin Pharmaceutical and Alliant Pharmaceuticals, a privately held pediatric specialty pharmaceutical company located in Alpharetta, Georgia, announced that the FDA has granted marketing approval for Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets), the first orally disintegrating tablet form of prednisolone available in the US. Alliant expects to begin marketing Orapred ODT in the United States in August or September of 2006.
Cephalon and Alkermes announced today that Vivitrol (naltrexone for extended-release injectable suspension), the first and only once-monthly injectable medication for alcohol dependence, is now commercially available in the US. Vivitrol is indicated for patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when initiating treatment.
The FDA has granted Merck and Schering Plough’s jointly-marketed Zetia an expanded indication. The drug’s makers won approval to market Zetia for use with the drug fenofibrate in the treatment of mixed hyperlipidemia -- a condition where patients suffer from high “bad” cholesterol and suffer from a lack of so-called “good” cholesterol. Previously, Zetia was only approved for the treatment of “bad” cholesterol, when diet and exercise alone were inadequate.