GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA approves first generic versions of celecoxib

May 30, 2014

Release

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.

In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Information about the availability of generic celecoxib can be obtained from the companies.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

COMPANY RECALLS ALL 2012 CANTALOUPES BECAUSE OF POSSIBLE SALMONELLA CONTAMINATION

Chamberlain Farm Produce, Inc. Recalls Cantaloupes Because Of Possible Health Risk

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE - August 22, 2012 - Chamberlain Farm Produce, Inc., of Owensville, Indiana, is voluntarily recalling all of its cantaloupes from the 2012 growing season that may remain in the marketplace. This recall is occurring because of concern some cantaloupes may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

This voluntary recall follows a prior voluntary market withdrawal of all Chamberlain Farm Produce, Inc. cantaloupes that occurred August 16 and 17, 2012.

During the period June 21, 2012 to August 16, 2012, Chamberlain Farm Produce, Inc., marketed cantaloupes to four retail grocery stores with grocery store retail outlets in Vanderburgh, Warrick, Gibson, and Dubois County, Indiana, and Wabash County, Illinois; and also to four wholesale purchasers located in Owensboro, Kentucky, St. Louis, Missouri, Peru, Illinois, and Durant, Iowa, respectively. As a part of the voluntary market withdrawal, Chamberlain Farm Produce, Inc. notified all of the purchasers of its cantaloupes to take immediate action to remove all Chamberlain Farm Produce, Inc. cantaloupes from the marketplace, and all of the purchasers confirmed compliance with that request.

The CDC reports that for the period July 7, 2012, through August 22, 2012, there have been reports of some 178 persons nationwide who may have become sick in connection with consumption of cantaloupes. The FDA investigation is ongoing and incomplete at this time. After discussion with the FDA, Chamberlain Farm Produce, Inc., decided to conduct the recall as a precautionary measure.

Consumers should inquire about the source of cantaloupes before purchasing additional cantaloupes or using cantaloupes already purchased. To be absolutely certain, consumers should destroy any cantaloupes currently in their possession the origin of which cannot be identified.