SUPPLIER NEWS — The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.
Alza Corp. is attempting to block Impax Labs from developing a generic version of Alza’s attention deficit hyperactivity disorder treatment. Impax confirmed that Alza filed a patent infringement suit in the U.S. District Court for the District of Delaware against the generic drug maker in connection with Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg and 36-mg strengths, which are designed to treat ADHD in children ages 6 years and older, adolescents and adults up to the age of 65 years.
A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals. Mylan and its subsidiary Mylan Pharmaceuticals launched oxycodone and aspirin tablets USP in the 4.8355-mg/325-mg strength, based on an agreement with licensing partner Coastal Pharmaceuticals. The drug, designed to treat moderate to severe pain, is a generic version of Percodan.
The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said in May. Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidney and brain.
Greenstone has introduced an authorized generic treatment for breast cancer, the generics subsidiary of Pfizer said. The company announced the launch of exemestane tablets, an authorized generic version of Pfizer’s Aromasin. Aromasin is used to treat early breast cancer in menopausal women who already have taken the drug tamoxifen for two to three years, as well as breast cancer in women whose disease has worsened while taking tamoxifen, which is widely available as a generic. Authorized generics are branded drugs sold under their generic names at a reduced price.