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Biotech / Medical : Cor Therapeutics Inc. (CORR) -- Ignore unavailable to you. Want to Upgrade?


To: Haolin Ni who wrote (243)7/2/1998 7:40:00 PM
From: Robert Mayo  Read Replies (2) | Respond to of 712
 
All:

Spotted this on DJ wire:

"FDA Says Cor Therapeutics' Letter On Integrilin Incomplete

Dow Jones Newswires

"WASHINGTON -- Less than a month after its new heart drug, Integrilin, hit the market, Cor Therapeutics Inc. (CORR) received notice from the U.S. Food and Drug Administration that it improperly marketed the product.

"The FDA said that a letter the company sent to doctors and pharmacists announcing the new anti-clotting heart drug didn't properly warn about the drug's risks.

"Ellen Martin, Cor Therapeutics' vice president for regulatory affairs, said the company has drafted a letter to reply to the FDA. The FDA's notice of violation letter requires the company respond on or before July 10.

"Martin said full prescribing information, which explains the drug's risks, accompanied the letters Cor Therapeutics sent to health professionals.

"However, the FDA said the letter itself wasn't balanced.

"They thought the total safety information should have been included in the letter," Martin said.

"Integrilin hit the market June 8 as a treatment for patients undergoing angioplasty and for those with unstable angina."
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Bob