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The Food and Drug Administration has approved the first generic versions of Mobic (meloxicam) for the treatment of osteoarthritis.
The new approvals of 13 generic meloxicam applications stem from the agency's cluster review approach, aimed at increasing efficiency and decreasing review time for generic drugs.
The agency has begun to review groups of applications that are typically submitted at the end of 5-year new-chemical-entity exclusivity.
In the case of meloxicam, an NSAID, the FDA received more than 20 abbreviated new drug applications. The new approvals took the review team about 9 months to complete.
The Food and Drug Administration has approved the first generic versions of Mobic (meloxicam) for the treatment of osteoarthritis.
The new approvals of 13 generic meloxicam applications stem from the agency's cluster review approach, aimed at increasing efficiency and decreasing review time for generic drugs.
The agency has begun to review groups of applications that are typically submitted at the end of 5-year new-chemical-entity exclusivity.
In the case of meloxicam, an NSAID, the FDA received more than 20 abbreviated new drug applications. The new approvals took the review team about 9 months to complete.
The Food and Drug Administration has approved the first generic versions of Mobic (meloxicam) for the treatment of osteoarthritis.
The new approvals of 13 generic meloxicam applications stem from the agency's cluster review approach, aimed at increasing efficiency and decreasing review time for generic drugs.
The agency has begun to review groups of applications that are typically submitted at the end of 5-year new-chemical-entity exclusivity.
In the case of meloxicam, an NSAID, the FDA received more than 20 abbreviated new drug applications. The new approvals took the review team about 9 months to complete.