Table of Contents
Skin Stripping vs. Acne Bioequivalent Studies for Tretinoin Generics. Comments at FDA-Advisory Meeting Nov 17, 2000
Skin Stripping vs. Acne Studies
Acne Bioequivalence Studies
Acne Results: .1% Retin-A â vs. .1%Generic Total Lesion Counts 398 Patients Enrolled/330 Completed No statistical differences
Summary Topical Tretinoin Gel and Creams % Improvement Total Lesions at 12 wks
We received approval of middle 0.05% Cream by Clinical bracketing and IVR
Attempt of Spear to get waiver of lower strength for 0.01% gel
Attempt of Spear to get waiver of lower strength for 0.01% gel
Achieving approval for 0.01% Tretinoin gel Requires Clinical Study
Controversies with Skin Stripping
Controversies with Skin Stripping
Does Stratum Corneum Stripping Predict Activity in Sebaceous Glands?
Summary of Position
Potential negative Effect on the Generic Topical Products.
Skin Stripping vs. Acne Bioequivalent Studies for Tretinoin Generics. Comments at FDA-Advisory Meeting Nov 17, 2000
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