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The FDA has rejected Pain Therapeutics extended-release oxycodone Remoxy for the third time, issuing a complete response letter that hinges on the agency’s request for new studies to substantiate the product’s abuse-deterrence label claims. Read More
Alcon Pharmaceuticals is asking the FDA to apply stricter requirements on bioequivalence studies intended to supplement applications for Durezol and Ciprodex generics. Read More
A federal judge awarded Fresenius a preliminary injunction that blocks Fera Pharmaceuticals from marketing a levothyroxine sodium generic for the treatment of an underactive thyroid. Read More
The UK’s price watchdog has recommended reimbursement for Alexion Pharma’s Strensiq to treat perinatal- and infantile-onset hypophosphatasia and Gilead’s Epclusa to block the spread of hepatitis C virus genotypes to new cells, provided the companies discount the prices. Read More