FDA COMPLETES FIRST 'CLUSTER' GENERIC APPROVAL

The FDA has approved several first generic versions of Boehringer Ingelheim's Mobic Tablets, indicated for the treatment of osteoarthritis, an important step in the agency's effort to increase the availability of lower-cost generic medications.

The approval of meloxicam was the result of a "cluster" review approach, one of the process improvements the FDA has instituted to facilitate the review of generic drug applications. The FDA's Office of Generic Drugs (OGD) has begun to review groups of applications submitted at the end of five-year new chemical entity exclusivity in "clusters" to increase efficiency and decrease review time. At the end of the five-year period, the FDA often receives multiple applications from different sponsors, submitted on the same day.

In the case of meloxicam, OGD received more than 20 abbreviated new drug applications, and the FDA's review team effort resulted in the approval of 13 generic applications for this product in a little more than nine months of review time.