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Spear Pharmaceuticals Receives ANDA Approval for Tretinoin Cream USP, .05% (Emollient)

    NAPLES, Fla., Sept. 19 /PRNewswire/ -- 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(R) 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.

    For further information, e-mail us at http://www.Spearpharma.com

    Renova(R) is a registered trademark of OrthoNeutrogena, a Division of
Ortho-McNeil Pharmaceuticals, Inc.


SOURCE Spear Pharmaceuticals




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Related links:
  • http://www.spearpharma.com
    CONTACT:
    Michael Langer, VP of Finance & Marketing of
    Spear Dermatology Products, Inc., +1-973-895-6447