Generic Celebrex Approved by FDA

Generic Celebrex Approved by FDA

New and cheaper generic versions of the pain reliever Celebrex will soon be on the market – potentially saving patients hundreds of dollars a month.

The Food and Drug Administration has authorized two drug makers to sell celecoxib, the generic name of Celebrex, as a treatment for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and short-term acute pain.

Teva Pharmaceutical Industries (NYSE: TEVA) received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths. Teva was also given exclusive marketing rights for 180 days for the 100 mg, 200 mg, and 400 mg strength products.

Mylan Inc. (NASDAQ: MYL) only received approval from the FDA to market 50 mg celecoxib capsules. Mylan has filed a lawsuit against the agency, saying it “seriously erred” in its decision to give Teva 180 days exclusivity on the extra strength versions of celecoxib.

celebrex-packaging_646x312Celebrex has been a blockbuster drug for Pfizer (NYSE: PFE) since it was approved by the FDA in 1998. Last year the pain reliever was the fourth best-selling drug for Pfizer, with sales of nearly $3 billion.

A bottle of 60 capsules of Pfizer’s 200 mg Celebrex will cost a little over $400 according to GoodRx, a website that lists the cash price paid by uninsured patients at various pharmacies.

Generic prescription drugs generally cost 30 to 80 percent less than branded medications.

A spokeswoman for Teva told National Pain Report the company would not disclose the pricing or launch date for its generic celecoxib. Mylan did not respond to an inquiry.

“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, MD, 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 Cox-2 inhibitor and a non-steroidal anti-inflammatory drug (NSAID) that is only sold as a prescription. All NSAIDs have a “boxed warning” label that the drug raises the risk of heart attack or stroke. The risk increases for people with heart disease or who have risk factors for it, such as high blood pressure. The label also warns about the risk of gastrointestinal bleeding that has been associated with prolonged use of NSAIDs.

‘Snake Oil’ Neurontin Settlement

Meanwhile, Pfizer has disclosed an out-of-court settlement in which it agreed to pay $325 million to healthcare providers who claimed the drug maker illegally marketed the anti-seizure medication Neurontin for unapproved uses.

The drug is only approved by the FDA for the treatment of epilepsy and for neuropathic pain from shingles or herpes, although it is widely prescribed off-label for other conditions.

Neurontin, which is also known by its generic name gabapentin, was once infamously described by a top Pfizer executive as “snake oil.”

Neurontin was approved by the FDA in 1993 to treat epileptic seizures and in 2002 to treat some types of neuropathic pain. But it was also promoted by Pfizer for other uses through publications, medical seminars and in private communications with doctors, who began prescribing it off-label to treat bipolar disorder, depression, diabetic neuropathy, migraines and fibromyalgia. According to some estimates, over 90% of Neurontin sales are for off-label uses.

Neurontin’s popularity seemed to mystify some of Pfizer’s own executives. In a 1999 email under the subject heading “social phobia,” Christopher Wohlberg, who was then Pfizer’s executive medical director, wrote that “Gabapentin (Neurontin) is the ‘snake oil’ of the twentieth century. It has been reported to be successful in just about everything that they have studied.”

Another Pfizer executive wrote in a memo that there was “negligible evidence” supporting Neurontin’s use to treat bipolar disorder or depression.

In 2004 Pfizer agreed to pay $430 million dollars in fines to resolve misdemeanor criminal and civil charges for the off-label marketing of Neurontin.

This past April, Pfizer also agreed to pay $190 million to settle a lawsuit over claims it violated antitrust laws by blocking generic versions of Neurontin.

Authored by: Pat Anson, Editor