PharmaDerm Announces FDA Approval for ClindaMax Vaginal Cream.ATLANTA -- PharmaDerm today announced the approval from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for Clindamycin Phosphate clindamycin phosphate Cleocin Phosphate, Cleocin T, Clinda-Derm, Clindagel, ClindaMax, Clindets, Dalacin C Phosphate (CA), Dalacin T (CA) (UK), Zindaclin (UK) Pharmacologic class: Lincosamide Therapeutic class: Vaginal Cream USP USP - unique sales point , 2%, to be marketed as ClindaMax(R) Vaginal Cream. ClindaMax Vaginal Cream is a topical antibiotic cream prescribed for the treatment of Bacterial Vaginosis Bacterial Vaginosis Definition Bacterial vaginosis (BV) is a type of vaginal infection in which the normal balance of bacteria in the vagina is disrupted, allowing the overgrowth of harmful anaerobic bacteria at the expense of protective bacteria. (BV). Available only by prescription, ClindaMax Vaginal Cream is indicated for the three or seven day treatment of BV. "We are pleased to receive FDA approval for ClindaMax Vaginal Cream and look forward to introducing our new brand product to the OB/GYN medical community," said Malcolm McCoy, vice president of sales and marketing for PharmaDerm. ClindaMax Vaginal Cream will be available in a 40 g tube with seven disposable applicators. The company plans to market the new product in early 2005. (See product package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific for full prescribing information). About PharmaDerm PharmaDerm, headquartered in Atlanta, GA and a division of Altana Inc., is a specialty pharmaceutical manufacturer of topical steroids and antibiotics. PharmaDerm currently markets ApexiCon, LoKara, ClindaMax Gel and Lotion, and AlphaTrex Gel to the U.S. dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. community. For more information on PharmaDerm and a complete line of products, please call PharmaDerm Customer Service at (866) DERM-001 (337-6001) or visit the company online at http://www.pharmaderm.com. Statements about the organization's future expectations, other than historical facts, are "forward looking statements", based on appraisals by the PharmaDerm management and information currently available to PharmaDerm. Factors, which PharmaDerm cannot predict with certainty, may cause actual results to vary substantially from those specifically or implicitly expected in these statements. (R)ClindaMax Vaginal Cream is a registered trademark of PharmaDerm. (C)2004 PharmaDerm, Atlanta, GA. |
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