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"...
You may also be interested in...
Wyeth’s second low-dose HRT
Wyeth plans to launch low-dose Premarin (.45 mg estrogens) this summer along with the recently approved low-dose PremPro (.45 mg estrogens/1.5 mg medroxyprogesterone). FDA cleared the Premarin formulation April 25; low-dose PremPro was approved March 12 (1Pharmaceutical Approvals Monthly April 1, In Brief). The product's estrogen content is 28% less than the standard .625 mg dose, which Wyeth says allows for "better individualization of therapy, particularly for new patients." The firm hopes that the low-dose products will allay concerns stemming from the Women's Health Initiative stud
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.