The FDA has approved Sanofi-Aventis’ 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.
The FDA will apply an additional six months of market exclusivity to Cephalon’s Provigil (modafinil) tablets. The extension attaches to the US patent covering Provigil, such that the associated exclusivity now extends until April 6, 2015.
Santarus this week launched Zegerid (omeprazole/sodium bicarbonate) capsules, an immediate-release proton pump inhibitor (PPI). Zegerid capsules were approved by the FDA on Feb. 27, 2006.
GlaxoSmithKline announced that the FDA has approved the use of Flovent HFA in children 4 to 11 years of age with asthma. Flovent HFA is a reformulation of the asthma medication Flovent (fluticasone propionate) inhalation aerosol, which uses hydrofluoroalkane (HFA-134a) to propel the medication out of the canister and into the lungs. Hydrofluoroalkane replaces the chlorofluorocarbon (CFC) propellant and is more ozone friendly. This approval supports GSK's commitment to a CFC-free portfolio of respiratory products.
Novo Nordisk’s new long-acting basal insulin analog Levemir (insulin detemir [rDNA origin] injection) is now available in the US. Levemir is indicated for once- or twice-daily injection for the treatment of adults and children with type 1 diabetes and adults with type 2 diabetes.
The FDA has approved Amgen’s every-three-week dosing of Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia (low red-blood-cell count) in patients with non-myeloid malignancies.