News
Akorn-Strides' rifampin cleared by FDA
Akorn-Strides has announced the approval of an Abbreviated New Drug Application for rifampin for injection USP, 600mg/vial. This is the first lyophilized Injectable product approval for the Joint Venture.
The company is a joint venture that was formed in 2005 by USA-based Akorn and Strides Arcolab of India. The primary mission for the JV 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.
Rifampin for injection is a semi-synthetic antibiotic indicated for the treatment of both tuberculosis and meningococcal carriers. Recent IMS Health data estimates an annual market size of around $11.0 million in the USA.
The current product portfolio of the JV, which is funded equally by Akorn and Strides Arcolab, was recently expanded and now includes 29 ANDAs with a total of 53 product line offerings. To date, the firm has filed for 18 ANDAs and received seven approvals. It expects to generate product revenues in 2008 based on this and future product approvals, as well as subsequent launches.