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A federal judge has ruled that Par Pharmaceutical’s generic version of the Novartis Alzheimer’s treatment Exelon Patch did not infringe on the brand manufacturer’s patent. Read More
Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market a generic version. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA GMPs, creating another quality headache for the Indian drugmaker. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials, and nine lots due to particulates in vials. Read More
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
Generics manufacturers Mylan, Momenta and Sandoz have joined Dr. Reddy’s Laboratories as some of the first to announce patent challenges against Teva’s blockbuster multiple sclerosis drug Copaxone in the newer 40 mg version. Read More