Barr low-dose Cenestin "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Barr's 0.45 mg formulation of its plant-derived hormone therapy Cenestin receives "not approvable" letter, firm announces June 3. The 0.45 mg synthetic conjugated estrogens tablet is under review for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Cenestin is currently available in 0.3 mg, 0.625 mg, 0.9 mg and 1.25 mg tablets, but the 0.3 mg dosage strength is indicated only for the treatment of vulvar and vaginal atrophy. The agency's decision follows recent approvals of low-dose formulations of Wyeth's Premarin and PremPro (1Pharmaceutical Approvals Monthly May 1, 2003, In Brief). Safety concerns from the Women's Health Initiative study have led to increased interest in lower dose hormone therapies. Barr plans to meet with FDA "as soon as possible"...
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