Endo Pharmaceuticals has announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information from Endo to address the agency’s concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.

For the full story, Click Here

Astellas Pharma Inc. and XenoPort, Inc. have announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The acceptance of filing of the NDA triggers a $5 million milestone payment from Astellas to XenoPort.

For the full story, Click Here

Eurand NV has received approval from the FDA for its New Drug Application (NDA) for ZENPEP (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. ZENPEP is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children aged one to 12 years. The drug will be available in four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.

Mylan Pharmaceuticals has received approval from the FDA for its abbreviated new drug application (NDA) for liothyronine sodium tablets USP. The drug will be available in the strengths of 5mcg, 25mcg and 50mcg. Liothyronine sodium tablets are the generic version of King Pharmaceuticals’s treatment for thyroid deficiency, Cytomel. The company has started the shipping of the product.