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The FDA has given Israel-based Teva Pharmaceutical and Ohio-based Roxane Laboratories the go-ahead to market generic versions of Pfizer's blockbuster antidepressant Zoloft, the agency said June 30, the same day Pfizer's patent expired.
The FDA is ordering California-based PrimaPharm to stop advertisements of its drug Hydase, saying that the ads are misleading because the company fails to communicate risks associated with the product.
French drugmaker sanofi-aventis has announced that the European Commission (EC) has granted marketing authorization for Acomplia (rimonabant 20 mg/day) in all 25 European member states.
In observance of the Independence Day holiday, Daily International Pharma Alert will not be published Tuesday, July 4. The next issue will be published Wednesday, July 5.
SkyePharma PLC announces that it has completed negotiations with Mundipharma International Holdings Limited the result of which is that SkyePharma will reacquire the rights for the marketing and distribution of DepoBupivacaine in Europe and other international markets excluding the USA, Canada and Japan. SkyePharma will also obtain rights to the clinical data from the Phase II trials of DepoBupivacaine.
Johnson & Johnson announced today that Janssen Pharmaceutica N.V., a Johnson & Johnson company, has entered into a collaboration with Vertex Pharmaceuticals Incorporated to develop and commercialize Vertex's investigational hepatitis C virus (HCV) protease inhibitor, VX-950.