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Last updated on April 18, 2014 at 16:49 EDT

Latest Food and Drug Administration Stories

2014-03-27 08:34:36

AVP-825 relies on novel closed palate Breath Powered(TM) drug delivery technology YARDLEY, Pa., March 27, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for AVP-825, an innovative closed-palate Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine. As previously reported, the 505(b)(2) NDA for AVP-825 includes clinical data developed by OptiNose including a pivotal phase...

2014-03-27 08:33:44

Jury awards Mylan $106.7 million in damages PITTSBURGH, March 27, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that, after a trial in the United States District Court for the District of New Jersey, a jury returned a verdict in favor of Mylan in its breach of contract lawsuit against GlaxoSmithKline (GSK) relating to Paroxetine Hydrochloride Extended-release (ER) Tablets. The jury decided that GSK owes Mylan $106.7 million in damages. Mylan's claims were based...

2014-03-27 08:33:35

ATLANTA, March 27, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has resubmitted its New Drug Application for ILUVIEN(®) to the U.S. Food and Drug Administration (FDA). At this time, Alimera awaits the FDA's acceptance of the resubmission and a Prescription Drug User Fee Act (PDUFA) date. Alimera...

2014-03-27 08:29:37

NEW YORK, March 27, 2014 /PRNewswire/ -- Across the globe, there are over 13 million new cancer cases each year. By 2030, it is estimated by the International Agency for Research on Cancer (IARC) that there will be approximately 21.4 million new cancer cases and 13.2 million cancer deaths worldwide. Some of the more common (and deadly) forms of cancer are head and neck cancer, which account for approximately 600,000 new cases worldwide each year and result in a five-year survival rate...

2014-03-26 23:33:00

The Corporate Whistleblower Center is strongly encouraging pharmaceutical industry insiders, or physicians to call them at 866-714-6466 if they possess substantial proof a drug company is knowingly off-labeling their pharmaceutical product as a way to increase profits, as pointed out in a recent Justice Department press release. The Whistleblower Center believes off-labeling puts patients at risk, and well documented proof of this type of activity can produce substantial whistleblower...

2014-03-26 23:31:29

National network of attorneys continues to offer no-cost consultations to consumers over allegations that Lipitor and other statins increase the risk of developing diabetes. San Diego, CA (PRWEB) March 26, 2014 http://www.resource4thepeople.com/defectivedrugs/lipitor-lawsuit.html Resource4thePeople today announced an important legal update for consumers who are interested in litigation involving allegations that the anti-cholesterol medication Lipitor may cause patients to develop...

2014-03-26 08:30:13

ALISO VIEJO, Calif., March 26, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered(TM) investigational drug-device combination product for the acute treatment of migraine. http://photos.prnewswire.com/prnvar/20130207/LA55901LOGO As previously reported the company's 505(b)(2) NDA for AVP-825 includes data from...

2014-03-26 08:29:57

MOON TOWNSHIP, Pa., March 26, 2014 /PRNewswire/ -- GlaxoSmithKline (GSK) is alerting consumers that some bottles of its alli® over-the-counter weight loss medication have been tampered with. Consumer safety is GSK's primary concern. We have initiated an investigation and are working with the Food and Drug Administration. What Does The Tampered Product Look Like: -- The outer carton may look authentic. -- The bottle may contain a range of tablets and capsules of various shapes...

2014-03-26 08:29:20

Urges President to Support Safe and Effective Treatment for Duchenne Muscular Dystrophy WASHINGTON, March 26, 2014 /PRNewswire/ -- The Race to Yes, a national campaign by families with children facing death from Duchenne Muscular Dystrophy achieved an important milestone just after 8pm EDT last night when the 100,000th person signed their White House petition urging the U.S. Food and Drug Administration to approve a breakthrough drug that has been shown to halt the progress of the...

2014-03-26 08:28:35

Supplemental approval will expand PDT with Photofrin® treatments in specific lung and esophageal cancers TORONTO AND BANNOCKBURN, IL, March 26, 2014 /PRNewswire/ - Concordia Healthcare Corp. (Concordia or the Company) (TSX:CXR) (OTCQX: CHEHF) announced today that its subsidiary Pinnacle Biologics, Inc. (Pinnacle), a biopharmaceutical research and development company specializing in rare diseases, was granted U.S. Food and Drug Administration (FDA) premarket supplemental...


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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