Amneal Pharmaceuticals announced four new additions to its portfolio of generic drugs, which represent multiple therapeutic categories and account for $900 million annually in U.S. sales, the company said, citing data from IMS Health.
The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.
The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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.