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Latest Food and Drug Administration Stories

2014-07-08 16:25:34

DUBLIN, July 8, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Dalfampridine Extended-release Tablets, 10 mg. Actavis' ANDA product is a generic version of Acorda Therapeutics' Ampyra(®), which is indicated as a treatment to improve walking in patients with multiple sclerosis. Acorda Therapeutics, Inc. filed suit against Actavis on...

2014-07-08 12:28:45

CHARLOTTE, N.C., July 8, 2014 /PRNewswire/ -- UniStrip Technologies, LLC of Charlotte NC has filed an antitrust lawsuit in the Los Angeles federal court against LifeScan, Inc., a Johnson & Johnson Company, for violations of the Sherman and Clayton Acts. In November, 2013 the FDA cleared UniStrip to market test strips that are compatible with four of LifeScan's OneTouch Ultra blood glucose meters. The key to UniStrip's success would be its highly accurate strips, as cleared by...

2014-07-08 08:31:22

- Toujeo dossier already accepted by EMA - PARIS, July 8, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for...

2014-07-08 08:31:18

Anticipated FDA action set for October 2014 STAMFORD, Conn., July 8, 2014 /PRNewswire/ -- Purdue Pharma L.P. announced that the U.S. Food & Drug Administration (FDA) has granted Priority Review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet (HYD). This investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by...

2014-07-08 08:30:07

PITTSBURGH, July 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, the generic version of Boehringer Ingelheim's Micardis® Tablets. 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 hypertension, to lower blood pressure. Telmisartan Tablets USP, 20 mg, 40 mg and 80...

2014-07-07 04:20:56

- MAA submission triggers $5 million milestone payment to AcelRx REDWOOD CITY, Calif. and AACHEN, Germany, July 7, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) and Grunenthal Group announced today that Grunenthal has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for ZALVISO(TM) for the management of moderate to severe acute pain in adult patients in a medically supervised environment. ZALVISO(TM) is a drug-device...

2014-07-06 23:02:37

ReportsnReports.com adds “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - Saudi Arabia” to its store. The value of the pharmaceutical market in Saudi Arabia expected to increase at a CAGR of 5.8% to 2020. Dallas, Texas (PRWEB) July 06, 2014 A high burden of chronic diseases, improving regulatory guidelines and the launch of new products will provide the necessary impetus for the growth of the pharmaceutical market in Saudi Arabia. The Saudi pharmaceutical market is...

2014-07-04 23:04:02

On June 30, the FDA warned not to use injectable vitamin drug products labeled “Sunshine Labs” and distributed by Medical Supply Liquidators because they are not FDA approved. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 04, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Injectable Vitamin...

2014-07-04 23:02:00

Fresenius Medical Care North America Recalls 56 Lots of Liquid Bicarbonate Concentrate DALLAS (PRWEB) July 04, 2014 Fresenius Medical Care North America, manufacturer of the dialysis drugs GranuFlo and NaturaLyte, has recalled 56 lots of NaturaLyte due to finding higher bacteria levels than allowed by internal specifications. The company is involved in litigation in a Massachusetts federal court where more than 1,700 lawsuits have been filed in conjunction with a previous recall. (In Re:...

2014-07-03 23:09:54

On June 26, the FDA informed that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. (PRWEB) July 03, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for Lidocaine Viscous. The FDA issued a safety...


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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Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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