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Apicore Pharmaceutical petitioned the FDA to require that any ANDA for Penicillamine capsules should use a specific method to show bioequivalence. Read More
The House Judiciary Committee voted unanimously in a Wednesday evening markup hearing to advance two bills that crack down on anticompetitive patent tactics wielded by drugmakers. Read More
The FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance released Wednesday. Read More
The FDA published its fall regulatory agenda on Wednesday for upcoming proposed and final rulemakings, including the following planned actions: Read More
In his mostly smooth Senate confirmation hearing on Wednesday, the administration’s nominee for FDA commissioner said there are some indirect actions the FDA could take to lower drug prices, although he demurred on giving a direct example. Read More
The approval brings Glenmark’s portfolio to 162 products authorized for distribution in the U.S., with 46 ANDA’s pending approval, the company said. Read More