United States Food and Drug Administration
Perrigo Company (Nasdaq: PRGO) announced that it has received U.S. Food and Drug Administration approval for its New Drug Application for testosterone gel 1%. Perrigo’s NDA included a bioequivalence study that compared its product to AbbVie’s AndroGel 1%.
Perrigo Co. (Nasdaq: PRGO) Tuesday announced that its partner, Cobrek Pharmaceuticals Inc., received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for betamethasone valerate foam 0.12 percent, the generic equivalent of Luxiq Foam.
The Stryker Neurovascular business of Stryker Corp. announced that its Trevo Pro Retriever blood clot remover has been granted 510(k) market clearance by the United States Food and Drug Administration,
Perrigo Co. (Nasdaq: PRGO) announced that the United States Food and Drug Administration has granted final approval to Tris Pharma for its abbreviated new drug application for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser’s Delsym suspension.
RetroSense Therapeutics, a gene therapy company dedicated to vision restoration, announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research division of the FDA that took place on May 22 regarding RetroSense’s lead product candidate, RST-001 for vision restoration in retinal degenerative conditions.
Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the United States Food and Drug Administration an Abbreviated New Drug Application for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals Inc., the owner of the New Drug Application of its filing.
The International Food Protection Training Institute, a non-profit organization delivering career-spanning, standards-based training to food safety officials, announced it had received a multi-year grant of $1.3 million per year from the United States Food and Drug Administration.
Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for over-the-counter Ranitidine 150 (regular and cool mint), a generic version of Zantac 150.
Allegan-based Perrigo Co. announced that it had achieved “acceptable regulatory status” in a re-inspection of its Allegal manufacturing plant by the Detroit office of the United States Food and Drug Administration.
More news on clinical trials for stem cell cures for some of mankind’s most dreaded diseases emerged Tuesday from the World Stem Cell Summit in Detroit. Thomas Okarma, president and CEO of Menlo Park, Calif.-based […]