You are here

Bristol-Myers Squibb Intends To Bring Pravastatin Over the Counter

PRINCETON, N.J., Dec. 10 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that it intends to pursue U.S. Food and Drug Administration (FDA) approval for an over-the-counter (OTC) version of Pravachol(R) (pravastatin sodium) 20 mg as a cholesterol-lowering treatment option in the United States. Pravachol(R) is approved in the United States only as a prescription drug.

The company also said that it has entered into an agreement with Bayer HealthCare LLC for Bayer's Consumer Care Division to handle OTC sales and marketing for pravastatin 20 mg in the United States, should the FDA approve OTC use of the drug. Bayer was selected given its experience in the cardiovascular category and the leadership position it has achieved in the marketing of the Bayer(R) Aspirin brand.

About Pravachol(R)
Pravachol(R) (pravastatin sodium), a prescription drug, is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough. Pravachol is not for everyone, including women who are pregnant or nursing or may become pregnant, or people with liver problems. And because serious side effects can result, patients should tell their doctor about any unexplained muscle pain or weakness they experience while on Pravachol, and about any other medications they are taking. Doctors may do blood tests to check for liver problems. It is recommended that liver function tests be performed prior to initiating therapy, prior to increasing the dose, and when otherwise clinically indicated. If a patient develops increased transaminase levels, or signs and symptoms of liver disease, more frequent monitoring may be required, and withdrawal of pravastatin therapy is recommended if an increase in AST or ALT of three times the upper limit of normal or greater persists. Some mild side effects, such as slight rash or stomach upset, occurred in two to four percent of patients.

Source: Bristol-Myers Squibb

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
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
Study lists steps that could save close to $300 billion a year