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Last updated on April 17, 2014 at 11:47 EDT

Latest Food and Drug Administration Stories

2014-04-14 12:33:11

PDUFA goal date set for September 26, 2014 ATLANTA, April 14, 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 its recent resubmission of the New Drug Application (NDA) for ILUVIEN(®) has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete class 2 response to the...

2014-04-11 23:22:36

The FDA warned consumers on April 8, to immediately stop using Zi Xiu Tang Bee Pollen capsules by Guangzhou Zi Xiu Tang Biotechnology Co. Ltd, because there were found to contain undeclared drug ingredients. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 11, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from...

2014-04-11 23:03:30

ExcelHealth launches it's new pain relieving TENS device now available to consumers without a Doctor’s prescription. Billings, MT (PRWEB) April 11, 2014 ExcelHealth Inc. announced today its new dual channel electrotherapy TENS Device for relief of muscle and joint pain. The iReliev Pain Management System (ET-1313) is FDA approved and now available to consumers without a prescription. The medical community has for over 30 years recommend their patients use a TENS unit for minor and...

2014-04-11 08:24:31

PITTSBURGH, April 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5 mg. This product is the generic version of FROVA(®), which is used to treat acute...

2014-04-11 08:24:24

HAYWARD, Calif., April 11, 2014 /PRNewswire/ -- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease (PD). After discussions with the FDA, the Company has...

2014-04-10 23:29:52

More Than 30 AndroGel Lawsuits Have Been Filed in Federal Courts Since FDA Announced Safety Review of Heart Risks Potentially Associated with Low Testosterone Therapy Medications. Columbus, OH (PRWEB) April 10, 2014 With more than 30 AndroGel lawsuits now pending in federal courts around the country, plaintiffs are seeking to have the cases consolidated in a multidistrict litigation and transferred to U.S. District Court, Northern District of Illinois for coordinated pretrial proceedings....

2014-04-10 23:27:26

On April 2, the FDA announced the nationwide recall of the optional PS500 Power Supply Unit used with the Evita V500 and Babylog VN500 ventilators by Dräger due to early depletion of battery charge. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 10, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the...

2014-04-10 23:02:16

Transparency Market Research Report added "Global Biological Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019" to its database. Browse full report: http://www.transparencymarketresearch.com/biological-drugs-market.html. (PRWEB) April 10, 2014 Biological drugs are biological medical products whose active drug substance is extracted by using living organism. The active substance is derived from living organism by the usage of...

2014-04-10 08:30:41

Spending on Compounded Medications More Than Doubled in 2013 ST. LOUIS, April 10, 2014 /PRNewswire/ -- Significant increases in cost per prescription drove drug trend for workers' compensation payers higher in 2013, according to research released this week by Express Scripts (NASDAQ: ESRX). Overall pharmacy spending for workers' compensation increased 9.5 percent, according to the Express Scripts Workers' Compensation Drug Trend Report, primarily from an 8.2 percent jump in cost per...

2014-04-10 08:29:04

DUBLIN, April 10, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/t45c8d/fda_approval) has announced the addition of the "FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)" [http://www.researchandmarkets.com/research/t45c8d/fda_approval ]conference to their offering. (Photo: http://photos.prnewswire.com/prnh/20130307/600769 ) The FDA Approval Process...


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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