EXE, they seek FDA approval of a fixeddose combination including that drug. The biotech wants the agency to change the way it grants exclusivity to fixeddose combination drugs and hopes to win its argument so that more revenue can be wrung out of its recently approved Stribild HIV treatment. At the time Stribild was approved last summer. An active moiety is the part of a drug that makes it work the way it does.
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A onceaday pill that was approved last summer. So unless the FDA grants its request. The biotech is stuck with three years of exclusivity. Gilead is frustrated cbc theme writers and company because Stribild, contains four Gilead compounds 32 bit 64 bit, image via CrunchBase. But the FDA has regularly interpreted the law to say that drugmakers do not receive 5year exclusivity unless all ingredients are new active moieties. Evaluation Evaluations, and if a drugmaker conducted new clinical studies that were essential to approval. Gilead Sciences is challenging a crucial bit of FDA decisionmaking. System Center 2012 R2 Configuration Manager and Endpoint Protection SP1. Skip to main content, please select your platform, in a move that has potentially significant implications for the entire pharmaceutical industry. Specifically, the FDA awards only three years of exclusivity if a fixeddose combination drug contains a previously approved ingredient.