💊FDA Decision on MOBIC Allows Continued Generic Approvals
Determination That MOBIC (Meloxicam) Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The determination by the FDA permits the continued approval of abbreviated new drug applications (ANDAs) for MOBIC (meloxicam), ensuring market viability and competition for generic manufacturers. This could lead to potential profitability for companies producing generic alternatives.