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FDA warns on unsubstantiated claims for Ista's Xibrom and Sirion's Durezol
A professional sales aid in support of Ista Pharmaceuticals' NSAID eye drop Xibrom (bromfenac ophthalmic solution) makes unsubstantiated superiority claims, br FDA warns on unsubstantiated claims for Ista's Xibrom and Sirion's Durezol.
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FDA Warns Ista on Marketing of Flagship Drug
The Food and Drug Administration has sent a warning letter to Irvine-based eye drug maker Ista Pharmaceuticals Inc.about advertising for its flagship product. Regulators said marketing material for Ista's Xibrom drug for treating pain after cataract...
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FDA issues warning to Ista over misleading sales materials
The U.S.Food and Drug Administration has issued a warning letter to Ista Pharmaceuticals in reference to advertising materials used to market the drug Xibrom. In a letter to the company posted on the FDA Web site, Division of Drug Marketing,...
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ISTA gets FDA warning regarding ad for eye solution Xibrom
ISTA Pharmaceuticals received a warning letter from the FDA over an advertisement about the benefits of eye drug Xibrom.- More - The only sales and marketing event for the device and diagnostics community. Step back from communicating product...
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Frost & Sullivan Presents the 2010 Excellence in Medical Devices and Life Sciences Awards
Agfa HealthCare - 2010 North American Imaging Informatics Product Leadership Award Astellas Pharma U.S., Inc.- 2010 North American Overactive Bladder Market Product Line Strategy of the Year Award Aton Pharma, Inc. - 2010 U.S. Ophthalmologistsescape...
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DDMAC demands corrective messaging from three companies
The FDA hit three companies with warning letters for promotional materials on three drugs and requested corrective communications for all three.The move suggests that requests for corrective communications -- which could range from "Dear Doctor" letters to TV...
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US FDA warns Ista on claims in eye drug promotion
* FDA says Xibrom promotion was misleading * Agency says Ista overstated efficacy, minimized risks WASHINGTON, March 16 (Reuters) - Ista Pharmaceuticals Inc made misleading claims about Xibrom eye solution in sales material, U.S.regulators said...
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UPDATE 1-US FDA warns Ista on claims in eye drug promotion
WASHINGTON, March 16 (Reuters) - Ista Pharmaceuticals Inc made misleading claims about Xibrom eye solution in sales material, U.S.regulators said in a letter released on Tuesday. A professional sales aid for Xibrom overstates the drug's...
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UPDATE 1-US FDA warns Ista on claims in eye drug promotion
WASHINGTON, March 16 (Reuters) - Ista Pharmaceuticals Inc made misleading claims about Xibrom eye solution in sales material, U.S.regulators said in a letter released on Tuesday. A professional sales aid for Xibrom overstates the drug's...
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FDA Warns ISTA Pharmaceuticals Over Sales Ad For Xibrom
WASHINGTON -(Dow Jones)- The U.S.Food and Drug Administration said a professional sales ad for ISTA Pharmaceuticals Inc.'s (ISTA) eye solution Xibrom is misleading because it suggests the product is more safe and effective than it is. The ad omits...
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FDA Warns ISTA Pharmaceuticals Over Sales Ad For Xibrom
Dow Jones Newswires WASHINGTON -(Dow Jones)- The U.S.Food and Drug Administration said a professional sales ad for ISTA Pharmaceuticals Inc.'s (ISTA) eye solution Xibrom is misleading because it suggests the product is more safe and effective than it...
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FDA Warns ISTA Pharmaceuticals Over Sales Ad For Xibrom
Dow Jones Newswires WASHINGTON -(Dow Jones)- The U.S.Food and Drug Administration said a professional sales ad for ISTA Pharmaceuticals Inc.'s (ISTA) eye solution Xibrom is misleading because it suggests the product is more safe and effective than it...
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Ista receives October action date for FDA review of once-daily bromfenac ophthalmic solution
Submit a Comment IRVINE, Calif.- Ista Pharmaceuticals' supplemental new drug application for a once-daily dose of bromfenac ophthalmic solution has been accepted for review by the U.S. Food and Drug Administration, Ista announced in a press release.
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay
IRVINE, Calif., March 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc.( NASDAQ:ISTA) , today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay(TM) (bromfenac ophthalmic solution) has been accepted for review by the U...
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ISTA Pharmaceuticals, Inc. (ISTA) Receives PDUFA Action Date of October 16,
IRVINE, Calif., March 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc.(Nasdaq:ISTA - News), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the...
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has...
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has...
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has...
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has...
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ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
ISTA Pharmaceuticals, Inc.(Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has...
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ISTA Says FDA to Review Eye Drug by Oct. 16
ISTA Pharmaceuticals Inc.said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is...
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ISTA says FDA to review eye drug by Oct. 16
IRVINE, Calif.-- ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. The drug is a once-per-day version of Xibrom, a drug that is already...
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ISTA says FDA to review eye drug by Oct. 16
Share: Yahoo!Buzz Text tool name tool goes here The Associated Press IRVINE, Calif! -- ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. The...
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ISTA says FDA to review eye drug by Oct. 16
IRVINE, Calif.(AP) ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. The drug is a once-per-day version of Xibrom, a drug that is...
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ISTA says FDA to review eye drug by Oct. 16
ISTA Pharmaceuticals Inc.said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is...
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