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Novartis will pay more than $35 million to settle off-label promotion charges when the company marketed its eczema cream, Elidel, for use on infants. Read More
The FDA published final guidance on its priority review voucher program for tropical diseases, saying that a voucher does not offer a complete guarantee of an approval within six months. Read More
Sen. Charles Grassley (R-Iowa) is pressing Mylan and the Centers for Medicare and Medicaid Services for answers on the misclassification of the company’s EpiPen as a generic for the agency’s drug rebate program. Read More
The FDA has published 30 new product-specific recommendations on the design of bioequivalence studies for ANDAs, while also revising 30 of its previous recommendations. Read More
Par Pharmaceuticals has sued the FDA for not granting the company 180 days of marketing exclusivity for its first generic of Takeda Pharmaceutical’s Colcrys, asking a federal court to enjoin the agency from approving any competing generics. Read More