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In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
Swiss-based Helsinn Healthcare has settled patent litigation with Dr. Reddy’s Laboratories, allowing the Indian genericsmaker to sell a generic version of the anti-nausea injection Aloxi starting in 2018. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More
Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Just days after the Trans-Pacific Partnership pact cut exclusivity protections for drugmakers outside the U.S., a proposal that would extend a waiver allowing poor countries to ignore drug patent laws is raising more ire. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
A federal appeals court has refused to rehear the biosimilars case pitting Sandoz against Amgen, letting stand a July decision allowing Sandoz to launch its Zarxio biosimilar of Amgen’s cancer therapy Neupogen (filgrastim) in September. Read More