GENERIC MELOXICAM APPROVED QUICKLY THROUGH "CLUSTER REVIEW"

Pharmacy Times, Volume 0, 0

The cost of treating osteoarthritis is likelyto drop quickly as a result of the FDA'sapproval of several first-generic versions ofBoehringer Ingelheim's Mobic Tablets(meloxicam). The FDA's approval of genericmeloxicam came as a result of a "clusterreview" of applications from several manufacturers—an approach designed to cutgeneric review time at the agency and toenhance the efficiency of the FDA's Officeof Generic Drugs (OGD).

At the expiration of a product's 5-yearexclusivity, the FDA often receives multiple applications from differentgeneric sponsors, typically all submitted on the same day. Under thenew cluster review approach, the OGD will review all of these applicationssimultaneously.

In the case of meloxicam, the OGD received more than 20 abbreviatednew drug applications. The FDA's review resulted in the approval of13 generic applications for this product in just over 9 months.

"This is another example of our agency's endeavor to counter risinghealth care costs by approving safe and effective generic alternatives tobrand name drugs," said Gary Buehler, director of the OGD. "Meloxicamis a widely used nonsteroidal anti-inflammatory drug, and its generic versionscan bring significant savings to the millions of Americans withosteoarthritis."

Because all of the patents for Mobic have expired, the FDA's approvalof generic meloxicam "is likely to represent immediate savings to theAmerican public," the agency official said.