Caraco gets tentative FDA OK for generic Coreg tablets

By Angela McDaniels

Seattle, Jan. 31 - Caraco Pharmaceutical Laboratories Ltd. said the Food and Drug Administration has granted tentative approval to the company's amended New Drug Application for the remaining strengths of Carvedilol tablets.

Caraco's Carvedilol 6.25 mg, 12.5 mg and 25 mg tablets are the generic equivalent of GlaxoSmithKline's Coreg, which is indicated for the treatment of mild to severe heart failure of ischemic or cardiomyopathic origin. It is also indicated to reduce cardiovascular mortality and for the management of essential hypertension.

The company anticipates final approval of Carvedilol after the expiration of patent protection in March 2007.

"With these three additional strengths, we now have tentative approval on all currently marketed strengths of Carvedilol, our generic equivalent to Coreg," chief executive officer Daniel H. Movens said in a company news release.

Total annual U.S. sales of Coreg 6.25 mg, 12.5 mg and 25 mg tablets for all indications are about $900 million, according to the release.

Detroit-based Caraco develops, manufactures and distributes generic and private-label prescription drugs.

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