Akorn-Strides has announced that the FDA has granted approvals for two abbreviated new drug applications for sterile vancomycin HCl USP, 500mg/vial, 1g/vial and sterile vancomycin HCl USP, 5g/vial pharmacy bulk package
Akorn-Strides is a joint venture that was formed in 2004 by Akorn and Strides Arcolab. The primary mission for the joint venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and central nervous system medicines.
Sterile vancomycin HCl is an antibiotic indicated for the treatment of potentially life-threatening infections which cannot be treated with other effective antimicrobial drugs, including the penicillins and cephalosporins, the company said. The expected launch date for these two new products is the first half of 2009.
Arthur Przybyl, president and CEO of Akorn-Strides, said: "These two important product approvals represent the largest market size opportunity for the joint venture to date. I would like to personally thank Arun Kumar, co-founder of the Akorn-Strides joint venture, for having built the necessary manufacturing infrastructure to allow the joint venture to effectively compete for market share.