ReportersNotebook — Chain Pharmacy, 5/30/11
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.
Par to acquire Edict
WOODCLIFF LAKE, N.J. — Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.
Par said it will acquire Edict Pharmaceuticals for up to $37.6 million in cash and Par’s repayment of certain additional pre-close indebtedness. Par noted the acquisition is subject to customary conditions and approvals; the drug maker expects to complete the transaction by the end of the year.
Edict currently has seven abbreviated new drug applications filed with the Food and Drug Administration and one ANDA filed in the name of a development partner with an additional 14 products in development.
"This transaction enhances Par’s already successful research and development infrastructure and demonstrates Par’s intention to continue to build out our product development platform," Par president Paul Campanelli said. "Also, Edict’s facility adds significant operational capacity and provides business continuity protection for our Spring Valley, N.Y., facility."
Sutent OKed as pancreatic NET treatment
NEW YORK — The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.
Pfizer announced Friday the approval of Sutent (sunitinib malate) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with locally advanced disease that can’t be removed through surgery. Pancreatic NET is a rare cancer reported in 2 million to 4 million people worldwide every year.
“We are delighted that Sutent has been granted approval by the FDA as an effective treatment option for individuals with pancreatic NET,” said Mace Rothenberg, SVP clinical development and medical affairs for Pfizer’s oncology business unit. This approval represents the third disease indication for Sutent, which was approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor.
Imatinib is the generic name for Novartis’ drug Gleevec.