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Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
Iroko Pharmaceuticals’ low-dose painkiller Zorvolex is now available for patients with osteoarthritis pain, following FDA’s approval for the second indication. Read More
The FDA has warned four generic drug manufacturing facilities that they haven’t paid their GDUFA fees for the last two fiscal years, meaning all of their products are automatically misbranded. Read More
The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. Read More
New Jersey-based Eisai is suing the FDA over the exclusivity clock assigned to two of its products, claiming the government arbitrarily shortened its five-year exclusivity period from generics competition. Read More
Subsidiaries of generics maker Hetero Drugs can move forward with generic versions of the kidney drug PhosLo despite an ongoing lawsuit brought by patent owner Roxane Laboratories. Read More
To improve ANDA submissions, the FDA should spend more time with generics companies before they file an application, as is done with brand manufacturers in the run-up to an NDA, the Generic Pharmaceutical Association says. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo’s pain medication Opana ER. Read More