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FDA

Deli Products Recalled Due To Lysteria Concerns

There’s been a diced onion recall involving Spartan Stores.

WWJ Newsradio 950–07/27/2012

perrigo

Perrigo Receives FDA Approval for Calcium Acetate Capsules

Perrigo Co. announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps.

WWJ Newsradio 950–06/06/2012

perrigo

Perrigo Announces FDA Approval Of Generic Delsym

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.

WWJ Newsradio 950–05/31/2012

retrosense

RetroSense Therapeutics Completes pre-IND Meeting for RST-001

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.

WWJ Newsradio 950–05/24/2012

perrigo

Perrigo Receives FDA Approval for Butoconazole Nitrate 2 Percent Vaginal Cream

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.

WWJ Newsradio 950–05/23/2012

perrigo

Perrigo Announces FDA Final Approval, Launch of Store Brand Prevacid

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.

WWJ Newsradio 950–05/20/2012

michbio

MichBio to Visit Capitol Hill on Pending User Fee Reauthorizations

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.

WWJ Newsradio 950–05/07/2012

istockphoto

Bad Cheese Results In 4 Indictments

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.

WWJ Newsradio 950–04/19/2012

tangent medical

Tangent Medical Seeks Approval Of New Catheter System

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.

WWJ Newsradio 950–04/10/2012

Breakfast eggs

Michael Foods Widens Egg Recall

Michael Foods is recalling eggs in brine sold in 10- and 25-pound pails for institutional use in 34 states, including Michigan.

WWJ Newsradio 950–02/03/2012

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