Skin Stripping vs. Acne Bioequivalent Studies for Tretinoin Generics. Comments at FDA-Advisory Meeting Nov 17, 2000

4/16/01


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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 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

Author: Kim Spear