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+4 ·
Barrs Pliva gets US FDA approval for 10mg, 20mg, 40mg Pravastatin
Filed Nov 28, 2006 at 5:26 PM ·
Barr Pharmaceuticals Inc said its subsidiary, Pliva dd, received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets in 10mg, 20mg, and 40mg strengths.
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+10 ·
Pharmaxis soars on FDA approval for Bronchitol
Filed Nov 24, 2006 at 1:02 AM ·
PHARMAXIS shares soared by more than 8 per cent today after the company announced that the US Food and Drug Administration had granted its cystic fibrosis drug Bronchitol fast track status.
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+3 ·
Dr. Mark Schusterman Welcomes the FDA Approval of Silicone Gel
Filed Nov 24, 2006 at 1:02 AM ·
Dr. Mark Schusterman openly welcomed the landmark decision made on Friday, November 17, 2006 by the FDA to lift the ban on the use of silicone gel implants for cosmetic breast augmentation. This ban had been in place since 1991, not because of evidence stating the dangers, but rather the lack of data proving the gel implants were safe.
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Mentor Receives FDA Approval to Sell Its MemoryGel Breast
Filed Nov 19, 2006 at 9:35 PM ·
Mentor Corporation (NYSE:MNT), a leading supplier of medical products for the global aesthetic market, announced today that the U.S. Food and Drug Administration (FDA) has approved for sale the Company's MemoryGel(TM) silicone gel-filled breast implants with post-approval conditions. The products are indicated for women undergoing breast reconstruction and for women who are at least 22 years old undergoing breast augmentation.
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+64 ·
Novartis Delayed in bid for FDA approval of Galvus
Filed Nov 15, 2006 at 6:05 PM ·
It'll take a bit longer than expected for federal regulators to weigh in on a new diabetes drug.
Novartis says it'll be late February before the Food and Drug Administration decides whether to approve Galvus, a new oral treatment for Type Two diabetes.
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+1 ·
Viasys gets FDA approval on Sonara
Filed Nov 15, 2006 at 2:01 AM ·
Medical device maker Viasys Healthcare Inc. said Tuesday the Food and Drug Administration approved its blood flow measurement devices Sonara and Sonara/tek.
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+3 ·
Taro gets FDA approval for generic Mobic
Filed Nov 09, 2006 at 6:12 PM ·
Taro also reported today that it has received tentative approval from the FDA for its for Cetirizine Hydrochloride Syrup
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+1 ·
Mylan Gets FDA Approval for Doxycycline
Filed Nov 08, 2006 at 11:09 PM ·
Generic drug maker Mylan Laboratories Inc. on Wednesday said it received final approval from the Food and Drug Administration for all three strengths of its doxycycline tablets.
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+3 ·
Adolor plunges 43% on FDA approval delay, CTIC down 10%
Filed Nov 06, 2006 at 11:31 PM ·
Adolor Corp. (NYSE:ADLR) market cap was nearly halved this morning. ADLR share price plunged over 43% this morning in heavy trading as it went from yesterday's close of $13.94 to $7.91.
The Food and Drug Administration asked Adolor to supply it with more information regarding the company's Entereg drug, dealing it a major blow. Analysts were expecting an FDA approval of the drug this week.
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+3 ·
Gamida-Cell gets FDA approval for StemEx test
Filed Nov 06, 2006 at 11:31 PM ·
The test will be the equivalent of Phase III clinical trials, and if the results are satisfactory, the company expects to bring StemEx to the market in 2009.
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