Sanofi-Aventis announced that the FDA has approved the supplemental new drug application (sNDA) for Taxotere (docetaxel) injection concentrate in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastroesophageal (GE) junction, who have not received prior chemotherapy for advanced disease.
Chiron said it is recalling and withdrawing its measles, mumps and rubella vaccine Morupar, distributed to developing countries in 2005, due to a slightly higher rate of adverse effects than in similar vaccines.
Barr Pharmaceuticals said the FDA will not need to produce additional clinical data to support approval of its extended-cycle contraceptive Seasonique. In August the FDA said the drug could be approved but requested additional data to support Seasonique’s unique dosing regimen. Barr said it will continue to work with the FDA to resolve outstanding issues, including product labeling and post-marketing commitments.