FDA Advisory Committee Background Informationthe-counter or OTC) availability of the 10 mg dose of MEVACOR® (
lovastatin) for reduction of
... All of the information contained within this summary is extracted directly from
... I. BACKGROUNDIn the original NDA submission for nonprescription
lovastatin,
the ... The applicant has also summarized data from studies submitted to the NDA for prescription
lovastatin and
... MEMORANDUM OF CONSULTATIONThis memorandum addresses Section 1.6.1.2.5 entitled "Defining the Benefit of
Lovastatin 20 mg once daily in the Mevacor OTC Eligible Population"
... pptb. Has the sponsor provided adequate rationale for the use of a fixed dose of
lovastatin 20 mg to lower
... b. Has the potential hepatic risk of
lovastatin 20 mg in individuals
... Statin TalkLovastatin in vivo decreases cholesterol levels in the CNS and alters
... The recurrence of these particular malformations could be interpreted as unexpected given
... pptAre consumers sufficiently compliant in the OTC setting to derive clinical benefits of
lovastatin treatment over the long-term? Benefit and Risk
...