You are here

New Angina Indication Approved for Ranolazine

PALO ALTO, Calif., Jan. 27 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has approved Ranexa(TM) (ranolazine extended-release tablets).

The approved indication is as follows: Ranexa is indicated for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs. Ranexa should be used in combination with amlodipine, beta blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.

Complete prescribing information for Ranexa, including detailed safety and dosage information, will be available soon at www.cvt.com.

The approval of Ranexa marks the first new pharmaceutical approach to treat angina in more than 20 years in the United States. CV Therapeutics anticipates that Ranexa will be available in pharmacies in late March.

"Patients will now have access to a new angina therapy for the first time in decades," said Louis G. Lange, M.D., Ph.D., CV Therapeutics chairman and chief executive officer. "CV Therapeutics is very proud to have succeeded in bringing this innovative new product to the market, and we look forward to educating cardiology specialists about Ranexa."

To view the FDA release about ranolazine, click here.

Source: CV Therapeutics, Inc.

Recent Headlines

Scenesse is new treatment for people with rare, painful light sensitivity disease
Humira, Rituxan top list of drugs that added $5.1 billion to nation's health care bill
Lower court rulings cleared the way for generic versions of the MS drug
Maryland man wins lawsuit that alleges that the company's antipsychotic caused his gynecomastia
Antidepressants, ADHD meds are also used to self-poison
While many victims used THC, the cause remains elusive
Descovy joins Truvada, another Gilead product, in the HIV prophylaxis market
Data show PTC Therapeutics drug preserves lung function
U.S. maintains measles elimination status as NY outbreak ebbs