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Home Industry News GlaxoSmithKline Coreg CR NDA accepted for review

GlaxoSmithKline Coreg CR NDA accepted for review

15th March 2006

GlaxoSmithKline (GSK) has announced that its new drug application (NDA) for Coreg CR, has been accepted for review by the Food and Drug Administration (FDA) in the US.

The NDA for the beta-blocker controlled release drug was submitted at the end of December last year and GSK has said that the beta-blocker it releases, Coreg, is the only beta-blocker approved by the FDA to improve survival in certain heart failure scenarios.

The new controlled release version of the Coreg drug allows for once-a-day dosing through the controlled dissolution and absorption of Coreg. Recent trial results showed Coreg CR was superior to placebo at reducing blood pressure over 24 hours.

“This study showed that the new extended release formulation of carvedilol provided clinically meaningful blood pressure reductions in a dose-dependant manner for a 24-hour span,” said Dr Michael A Weber, professor of medicine, at the SUNY Downstate Medical College of Medicine, Brooklyn, New York.

“This blood pressure effect is noteworthy in light of guidelines recommending the use of long-acting medications that provide 24-hour efficacy to minimise blood pressure variability.”

Currently, Coreg users are required to take a twice daily dosage of the medication.

track© Adfero Ltd

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