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Last updated on April 17, 2014 at 9:10 EDT

Latest Food and Drug Administration Stories

2014-04-15 12:29:59

PITTSBURGH, April 15, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Eszopiclone Tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta(®). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of insomnia. Eszopiclone Tablets 1 mg, 2 mg, 3 mg had U.S. sales of approximately $851.8...

2014-04-15 08:30:06

Purchase adds global regulatory writing and submission services to Certara's drug development consulting expertise NEW YORK, April 15, 2014 /PRNewswire/ -- Arsenal Capital Partners, a leading New York based private equity firm that invests in middle market healthcare, specialty industrial, and financial services companies, announced today the acquisition of Synchrogenix, the leading regulatory writing and related services firm. Synchrogenix provides services to pharmaceutical,...

2014-04-15 08:29:48

PITTSBURGH, April 15, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that the Company's President and Chief Executive Officer, Patrick Daly, has been appointed to the Advanced Medical Technology Association's (AdvaMed) Board of Directors. AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around...

2014-04-15 08:29:42

DUBLIN, April 15, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Mylan Inc. and Famy Care Ltd. to settle all outstanding patent litigation related to Mylan's generic version of Generess(®) FE (norethindrone, ethinyl estradiol and ferrous fumarate chewable tablets). Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess(®) FE under its pending Abbreviated New Drug...

2014-04-14 23:12:02

National network of attorneys now offering no-cost consultations in connection with FDA's announcement that safety of testosterone treatments is under review. San Diego, CA (PRWEB) April 14, 2014 http://www.resource4thepeople.com/defectivedrugs/testosteronetreatments-lawsuits.html Resource4thePeople announced today its latest update for consumers who may be considering legal action over concerns about heart attacks and strokes from testosterone treatments as detailed in a recent Food...

2014-04-14 23:10:18

On April 11, the FDA advised consumers not to purchase or use Lite Fit USA as it was confirmed it contained sibutramine. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 14, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for medical products including weight loss products. As the...

2014-04-14 23:02:32

As drug and devicemakers well know, the convention floor is a great place to get new customers and make new sales. In the time it takes to hold a staff meeting or have a business lunch, learn how to implement a four-step audit process that teaches how to audit operations before the FDA or an international regulatory body catches a misstep. Falls Church (PRWEB) April 14, 2014 How to Train Your Staff to Spot Promotional Violations **FDAnews Webinar** April 24, 2014 — 1:30 p.m. – 3:00...

2014-04-14 23:01:22

The Firm is evaluating Testosterone lawsuits on behalf of individuals who experienced life-threatening heart problems, allegedly due to Testim and other low-testosterone therapies. New York, New York (PRWEB) April 14, 2014 Testosterone treatment lawsuits (http://www.testosteronelawsuitcenter.com/) are now being filed in courts around the country on behalf of men who allegedly suffered life-threatening heart problems due to prescription medications used to treat hypgonadism (low...

2014-04-14 12:37:01

ANDOVER, Mass., April 14, 2014 /PRNewswire/ -- The PROCEED II heart transplant Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS(TM)) -Heart platform were announced on Saturday, April 12, 2014 at the International Society for Heart and Lung Transplantation (ISHLT) 34(th) Annual Meeting and Scientific Sessions in San Diego, Calif. http://photos.prnewswire.com/prnvar/20130425/NE01744LOGO-b The OCS Heart PROCEED II FDA pivotal trial met its success...

2014-04-14 12:34:57

IRVINE, California, April 14, 2014 /PRNewswire/ -- Positions Syneron with Disruptive Product Offering in Fast Growing Body Contouring and Fat Treatment Market Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that it has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape...


Latest Food and Drug Administration Reference Libraries

Flavr Savr
2013-10-03 09:43:32

Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...

Chilean Sea Bass, Dissostichus eleginoides
2013-01-12 08:49:28

The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...

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