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BioComp Pharma launches first generic drug for Tindamax®

BioComp Pharma, Inc. launched Tinidazole 500, the first generic version of the FDA-approved drug Tindamax®. Tindamax ® is the only oral antimicrobial drug approved by the FDA for the treatment of both trichomoniasis (trich) and bacterial vaginosis (BV).

Generic drugs have the same active ingredients and efficacy as branded drugs but, on average, cost 30 to 80 percent less.[5] In 2007, the average price of a generic prescription drug was $34.34, while the average price of a brand-name prescription drug was $119.41, according to the National Association of Chain Drug Stores.[6]

With an estimated 7.4 million new cases of trich in men and women each year,[7] it is the most common curable sexually transmitted disease in young, sexually-active women in the United States.[8] BV affects almost one-third of women (29.2 percent) in the United States[9] and is the most common vaginal infection in women of childbearing age.[10]

Tindamax® is administered in one gram (two 500 mg tablets, once daily for five days) or two grams (four 500 mg tablets, once daily for two days) for the treatment of BV, compared to the twice daily, seven day oral dosing of metronidazole, the current standard of care. Tindamax® is administered as two grams (four 500 mg tablets for one day) for the treatment of trich. The drug’s formulation helps minimize treatment time by allowing for targeted dosing and a shorter course of therapy.

[5] Saving Money on Prescription Drugs. U.S. Food and Drug Administration. Accessed at: http://www.fda.gov/fdac/features/ 2005/505_save.html#generic. Last accessed: January 25, 2009

[6] Industry facts-at-a-glance. National Association of Chain Drug Stores. Accessed at: http://www.nacds.org/wmspage. cfm?parm1=507. Last accessed: January 25, 2009.

[7] Trichomoniasis - CDC Fact Sheet. Centers for Disease Control. Accessed at: http:// www.cdc.gov/STD/Trichomonas/STDFact- Trichomoniasis.htm. Last accessed: January 24, 2009.

[8] Trichomoniasis - CDC Fact Sheet. Centers for Disease Control. Accessed at: http:// www.cdc.gov/STD/Trichomonas/STDFact- Trichomoniasis.htm. Last accessed: January 24, 2009.

[9] J.E. Allsworth, J.F. Peipert. “Prevalence of Bacterial Vaginosis: 2001–2004 National Health and Nutrition Examination Survey Data,” Obstetrics and Gynecology 2007; 109(1): 114-120.

[10] Bacterial Vaginosis – CDC Fact Sheet. Centers for Disease Control. Accessed at: http://www.cdc.gov/STD/BV/STDFact-Bacterial- Vaginosis.htm . Last accessed: January 24, 2009.