Tretinoin Cream .05% (Emollient) approved by FDA as first generic to Renova®
September 20th, 2005
SPEAR PHARMACEUTICALS RECEIVES ANDA APPROVAL FOR TRETINOIN CREAM USP, .05% (EMOLLIENT)
Spear Pharmaceuticals is very pleased to announce the approval of Tretinoin Cream USP, .05% (Emollient) effective September 15, 2005. The Spear product is therapeutically equivalent to Johnson & Johnson Consumer Companies, Inc.'s Renova® Cream. K.L. Spear MD, President of Spear Pharmaceuticals, states that "In receiving another first ANDA approval, we are pleased to have overcome the clinical and technical challenges this product presented."
Spear's Tretinoin Cream USP .05% (Emollient) is indicated as an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin. Steve Basile, Senior Vice President of Sales & Marketing for Spear Dermatology Products, Inc., comments, "We realize that, based on the cosmetic nature of this product, the dynamics of the patient population, and the anticipated lack of third party reimbursement, Tretinoin Cream USP, .05% (Emollient) will not achieve penetration levels typically garnered in the generic marketplace. Therefore, Spear is exploring a number of strategic alternatives including, but not limited to, the branding and/or licensing of the product".
Once a strategic plan is finalized, Spear will notify the trade regarding product availability.
Contact Information: Michael Langer, Vice President, Marketing
Spear Dermatology Products, Inc.
For further information, e-mail us.
Renova™ is a registered trademark of OrthoNeutrogena, a Division of Ortho-McNeil Pharmaceuticals, Inc.