Joint Meeting of
NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
and
ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE
July 13, 2000
Mevacor NDA 21-213, Lovastatin, 10 mg
Merck and Company
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Food and Drug Administration
OPDRA Postmarketing Safety Review
June 9, 2000 Memorandum regarding proposed Rx to OTC switch for Lovastatin (Mevacor)
Medical Officer's Draft Review of New Drug Application
Clinical Pharmacology & Biopharmaceutics Review
Statistical Review and Evaluation