The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
BD Medical, a segment of BD, on Wednesday announced the retail pharmacy launch of BD AutoShield Duo, the only pen needle with patented dual front- and back-end shields that provides greater convenience and safety before and after injecting.
Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.
Lupin, along with certain U.S. drugmakers and private equity funds, mght be making plans to bid for a selection of older drugs from GlaxoSmithKline, according to Reuters, which cited sources familiar with the dealings.
Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.