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. announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1.
Perrigo Co. Friday announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun.
MichBio, the biosciences industry association in Michigan, announced today that it is visiting Capitol Hill Monday and Tuesday. The primary agenda item will be the pending User Fee reauthorizations — Prescription Drug User Fee Act and Medical Device User Fee Act (MDUFA) — as well as the new Generic Drug User Fee Act and Biologics and Interchangeable Products User Fee Act.
Prosecutors have announced the indictment of four people who are accused of ignoring FDA orders and distributing more than 110,000 pounds of Mexican cheese to five states, including Michigan.
Ann Arbor-based Tangent Medical Tuesday announced submission of a United States Food and Drug Administration 510(k) application for its NovaCath Secure IV Catheter System, developed from extensive clinical research of health care worker and patient needs.
Michael Foods is recalling eggs in brine sold in 10- and 25-pound pails for institutional use in 34 states, including Michigan.
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 recall involves certain bottles of the headache medicine Excedrin, NoDoz, Bufferin and Gas-X.