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FDA Issues Warning Letter to Skin Authority

2015-04-08 07:00:00| Happi Breaking News

Agency cites six products after website review.

Tags: issues letter skin authority

 

Gilead's low-dose, high-impact HIV drug heads to the FDA

2015-04-08 05:46:56| Biotech - Topix.net

A next-generation HIV drug from Gilead Sciences Inc. , which could be more effective and have fewer side effects with a lower dosage, will go to federal regulators for a decision on whether it should be approved. The drug - a combination of Gilead's emtricitabine and tenofovir alafenamide, or TAF - is the second so-called F/TAF drug submitted by the Foster City-based company to the Food and Drug Administration.

Tags: drug heads hiv fda

 
 

FDA Takes Cautious Tone In Initial Swedish Match Review Of Snus Smokeless Tobacco Products

2015-04-07 23:58:59| Appliances - Topix.net

The U.S. Food and Drug Administration said on Tuesday it is concerned that a Swedish Match AB proposal to soften warnings on its snus smokeless tobacco products would not accurately reflect the risks associated with snus use. Stockholm-based Swedish Match is seeking FDA approval of language stating that its snus products are less risky than cigarettes.

Tags: products review takes initial

 

FDA Withdraws Antifreeze Antidote for Dogs Approval

2015-04-07 16:59:49| Agriculture - Topix.net

Washington DC - infoZine - The U.S. Food and Drug Administration is announcing that it has withdrawn the approval for Antizol-Vet, also known as fomepizole, 4-methylpyrazole, or 4-MP, at the request of the drug's sponsor. Originally approved by FDA in 1996, Antizol-Vet is an antidote for ethylene glycol poisoning in dogs.

Tags: approval dogs fda antidote

 

FDA Withdraws Antifreeze Antidote for Dogs Approval

2015-04-07 16:08:24| Food - Topix.net

Washington DC - infoZine - The U.S. Food and Drug Administration is announcing that it has withdrawn the approval for Antizol-Vet, also known as fomepizole, 4-methylpyrazole, or 4-MP, at the request of the drug's sponsor. Originally approved by FDA in 1996, Antizol-Vet is an antidote for ethylene glycol poisoning in dogs.

Tags: approval dogs fda antidote

 

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