FDA Joint Advisory Committee Recommends Approval of Bayer Consumer Care's Ketoprofen Rx-to-OTC Switch

Business Wire, July 14, 1995

ROCKVILLE, Md.--(HealthWire)--July 14, 1995--A joint advisory committee of the U.S. Food and Drug Administration (FDA) today recommended that Bayer Consumer Care's ketoprofen, a non-steroidal anti-inflammatory (NSAID), be authorized for approval for over-the-counter (OTC) marketing.

The recommendation was issued at the conclusion of a hearing at which the joint advisory committee, which consists of the FDA Arthritis Advisory Committee and the Non-Prescription Drugs Advisory Committee, reviewed safety and efficacy data submitted by Bayer Consumer Care and Whitehall-Robins, two companies that have developed ketoprofen products for OTC use.

"We are very pleased with the joint advisory committee's decision to recommend approval of ketoprofen for OTC use," said Gary S. Balkema, president of Bayer Consumer Care. "We look forward to making ketoprofen more widely available to consumers nationwide."

When the FDA authorizes the approval of the drug, Bayer Consumer Care plans to market ketoprofen tablets for the temporary relief of minor aches, pains and fever associated with the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis and the pain of menstrual cramps.

"We are confident that ketoprofen, with its fast onset of action and short half-life, will offer an attractive choice for consumers seeking relief of minor aches, pains and fever," commented Steven M. Weisman, Ph.D., director of Medical and Clinical Affairs at Bayer Consumer Care.

"Moreover, the small tablet size of the 12.5 mg dose will be an additional benefit for consumers who have difficulty swallowing larger pills," Dr. Weisman added.

"Clinical trials have demonstrated a favorable safety and efficacy profile of ketoprofen, making it suitable for OTC use," said Timothy Shannon, M.D., deputy director of medical affairs at Bayer Corporation. "The availability of an OTC formulation of ketoprofen will offer consumers a new option in pain relief."

For more than 20 years, Bayer has marketed prescription (Rx) formulations of ketoprofen in 27 countries around the world. Ketoprofen is currently available in the U.S. by prescription for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea (menstrual cramps) and management of pain. The prescription dosage range is from 75 mg to 300 mg daily. More than 900 million doses have been dispensed in the U.S. since 1986.

With more than 5 billion doses of ketoprofen prescribed (Rx) worldwide, there have been relatively few reported side effects. The most common side effects are comparable to those of other prescription NSAID analgesics.

Bayer Consumer Care, located in Parsippany, NJ, is a division of Bayer Corporation (formerly Miles Inc.) which manufactures and markets prescription and non-prescription drugs worldwide.

Bayer Consumer Care is the maker of a number of products including Bayer(R) Aspirin, Alka-Seltzer(R), Mycelex(R)-7 and One-A-Day(R) vitamins. Bayer Corporation, the U.S. subsidiary of the international chemical and health care company, Bayer AG Germany, is a research-based company with major businesses in health care, chemicals and imaging technologies. Headquartered in Pittsburgh, Bayer Corporation employs 24,000 people and had sales of $7.1 billion in 1994.

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