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Latest Food and Drug Administration Stories

2014-05-30 16:25:02

DUBLIN, May 30, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that it has entered into an agreement with Cephalon, Inc. to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil(® )(armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg). Nuvigil(®) is a prescription medicine indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), shift work disorder (SWD) or...

2014-05-30 12:26:11

Expects to Imminently Receive Final Approval on 50 mg Strength; Has Received Tentative Approval on All Strengths PITTSBURGH, May 30, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the U.S. Food and Drug Administration (FDA), challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib...

2014-05-30 12:26:06

BETHESDA, Md., May 30, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) confirmed today the participation of five international experts for its upcoming 2014 PDA/FDA Virus and TSE Safety Conference, June 12-13, 2014, at the Hyatt Regency Hotel, Bethesda, Maryland. http://photos.prnewswire.com/prnvar/20130226/DC66667LOGO The five experts represent various countries, governmental and nongovernmental institutions, and will bring a wealth of knowledge and experience on the...

2014-05-29 23:15:44

On May 22, the FDA announced that Baxter Abacus TPN Calculation Software is recalled (Class I) because software errors may cause toxic/overdose symptoms. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) May 29, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for Baxter Abacus TPN...

2014-05-29 20:22:54

New offering through an agreement with Meda AB expands Mission's women's healthcare options SAN ANTONIO, May 29, 2014 /PRNewswire/ -- Mission Pharmacal Company has begun exclusive promotion of Elestrin® (estradiol gel) 0.06% in the United States through an agreement with Meda AB. Elestrin is a prescription medicine approved by the Food and Drug Administration (FDA) for use as a topical hormone replacement gel to treat moderate-to-severe hot flashes due to menopause. Using estrogen-alone may...

2014-05-29 08:29:40

MISSISSAUGA, ON, May 29, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products today announced that a third party has received U.S. Food and Drug Administration (FDA) approval to market and sell a topical diclofenac sodium 1.5% solution in the United States. The product is a generic version of Nuvo's PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID 1.5%). Mallinckrodt Inc. (NYSE:MNK)...

2014-05-29 08:29:36

REDWOOD CITY, Calif., May 29, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that senior management will present a corporate overview on June 3rd. Presentation details are as follows: Jefferies Global Healthcare ConferenceDate: June 3, 2014Location: Grand Hyatt New YorkPresentation Time: 1:30...

2014-05-29 08:29:06

PITTSBURGH, May 29, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Atovaquone and Proguanil Hydrochloride Tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone(®) 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 prophylaxis of Plasmodium falciparum malaria and the treatment of...

2014-05-28 23:16:04

On May 12, the FDA announced that Maquet Datascope Intra-Aortic Balloon Pumps are recalled due to failure of a fan assembly. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) May 28, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for Intra-Aortic Balloon Pumps. The FDA announced on May 12,...

2014-05-28 23:15:56

Transvaginal Mesh Attorneys Babbitt, Johnson, Osborne and Le Clainche explain the FDA proposal to reclassify surgical mesh to a “high risk” device for pelvic organ prolapse (POP). West Palm Beach, Florida (PRWEB) May 28, 2014 After six years and thousands of lawsuits for transvaginal mesh injuries, the U.S. Food and Drug Administration (FDA) is proposing to reclassify surgical mesh for pelvic organ prolapse (POP) repair to a “high-risk device.” A physician’s news service called,...


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
holluschickie
  • A 'bachelor seal'; a young male seal which is prevented from mating by its herd's older males (mated bulls defending their territory).
This comes from the Russian word for 'bachelors.'
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