Endo Pharmaceuticals Provides Regulatory Update on AVEED(TM) Injection
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.
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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.