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A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. 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
A federal appellate court upheld a district court dismissal of Mylan’s antitrust case against Warner Chilcott and Mayne Pharmaceuticals, which alleged that the name-brand drugmakers modified their acne treatment Doryx to block generic competition and maintain a monopoly on the market. 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
The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency. Read More
A federal judge rescinded his own verdict backing the FDA’s decision to not grant Ferring exclusivity for its bowel preparation drug Preponik, ruling that the agency must give the company five-years of retroactive exclusivity. Read More