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Latest Food and Drug Administration Stories

2014-09-08 08:29:19

Mylan Free to Immediately Resume Distribution of Its Generic Precedex Product PITTSBURGH, Sept. 8, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today commented on a ruling by the U.S. District Court for the District of Maryland related to its product, Dexmedetomidine Hydrochloride Injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL Single-dose Vials, which was approved by the U.S. Food and Drug Administration (FDA) as therapeutically equivalent to Hospira Inc.'s...

2014-09-06 08:20:30

NORTHBROOK, Ill., Sept. 6, 2014 /PRNewswire/ -- Astellas today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are life-threatening fungal infections predominantly occurring in immunocompromised patients. In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date...

2014-09-05 23:03:28

On September 2, the FDA announced that Solace International, Inc. is recalling all lots of Dermatend Original and Dermatend Ultra due to safety concerns. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) September 05, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Dermatend Original and Dermatend Ultra....

2014-09-05 23:01:22

The Firm is evaluating testosterone lawsuits on behalf of individuals who allegedly suffered serious cardiovascular complications, including heart attacks, strokes, deep vein thrombosis, and pulmonary embolism, due to their use of prescription testosterone therapy. New York, New York (PRWEB) September 05, 2014 The federal litigation involving the cardiovascular risks allegedly associated with prescription testosterone treatments (http://www.injurybeacon.com/testosterone-androgel/)...

2014-09-05 20:21:11

RANDOLPH, N.J., Sept. 5, 2014 /PRNewswire/ -- Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile. Pharmacy Creations no longer uses Front Range, Inc. for testing of any kind for any of its formulations. Although we cannot be certain that the product subject to the recall is contaminated,...

2014-09-05 16:23:02

NEWARK, Calif., Sept. 5, 2014 /PRNewswire/ -- Depomed, Inc. (Nasdaq:DEPO) today announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted Depomed's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration seeking an order requiring the FDA to grant Gralise(®) (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN). The court's ruling requires...

2014-09-05 08:23:23

MELBOURNE, Australia, Sept. 5, 2014 /PRNewswire/ -- Prana Biotechnology (ASX: PBT) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation to PBT2 for the treatment of Huntington Disease. Orphan drug designation is granted by the FDA to promote the development of drugs for diseases affecting less than 200,000 people in the United States. Orphan drug designation entitles Prana to seven years of market exclusivity for the use of PBT2 in the...

2014-09-05 08:23:21

PITTSBURGH, Sept. 5, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche's Boniva® Injection. 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 osteoporosis in...

2014-09-04 12:30:14

WINNETKA, Calif., Sept. 4, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc. (OTC Pink: GRCU) ("Green Cures") announced today that it is now working with Florida-based Nutritional Products International and InHealth Media for the distribution and marketing of Green Cures' nutritional, sports, hemp-infused and body care products across the U.S. market. "Our first marketing strategy is to promote and enhance our brands in targeted geographic locations, including...

2014-09-04 12:21:31

Conference attendees get chance to discuss visibility, collaboration and brand protection challenges with the experts MARLTON, N.J., Sept. 4, 2014 /PRNewswire/ -- Acsis Inc., the market leader for supply chain visibility, brand protection and serialization solutions, announced the company will be attending two major pharmaceutical industry conferences in September - PDA/FDA Joint Regulatory Conference, September 8-9 at the Renaissance Hotel, Washington DC, Booth # 58; and LogiPharma,...


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
negawatt
  • A unit of saved energy.
Coined by Amory Lovins, chairman of the Rocky Mountain Institute as a contraction of negative watt on the model of similar compounds like megawatt.