U.S. Food and Drug Administration

Perrigo Confirms First to File Patent Challenge for Generic Version of Testosterone Gel 1.62%

Perrigo Co. (Nasdaq: PRGO) announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for testosterone gel 1.62 percent and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.

WWJ Newsradio 950–2013/02/19

Awards And Certifications From January 16

Technology-related industry awards, recognitions, prizes and certifications earned by Michigan’s technology-focused companies, institutions, groups and people

WWJ Newsradio 950–2013/01/16

Ann Arbor’s NSF Buys D.C.-Based FDA Consulting Firm

NSF International, an independent global public health and safety organization which develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration-regulated industries, specifically medical devices, pharmaceuticals and biologics.

WWJ Newsradio 950–2012/08/02

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 950–2012/05/23

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 950–2012/05/20

Federal Court Building in Detroit 1-10-11

Feds Win Lawsuit Against West Michigan Dairy Farm

A Detroit federal judge rules that a western Michigan farm illegally sold cows for human food with unacceptably high levels of antibiotics.

WWJ Newsradio 950–2011/09/08

GeneGo's ToxHunter Suite Now Available

St. Joseph-based GeneGo this week announced the availability of ToxHunter, the first commercial release of tools and content developed through its industry-FDA MetaTox partnership program. ToxHunter is a unique comprehensive systems toxicology suite designed for […]

2010/07/13

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