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Allergan, along with Ironwood Pharmaceuticals, has filed a suit against five generics companies, alleging infringement of nine patents covering its irritable bowel syndrome drug, Linzess. Read More
The FDA rejected Vanda Pharmaceuticals petition to delay the approval of ANDAs referencing its schizophrenia therapy Fanapt until its three-year market exclusivity for a new indication expires. Read More
The FDA finalized its guidance for applicants on meeting regulatory requirements related to the content and formatting of the clinical pharmacology section of a proposed product label. Read More