Bangalore-based pharma firm, Strides Arcolab Limited today announced receipt of approval for its Abbreviated New Drug Application (ANDA) from USFDA to market Metoprolol Tartrate injection, USP commonly used in the treatment of acute myocardial infarction (AMI).
Metoprolol, which is a generic equivalent of Novartis Pharmaceutical Corporation's Lopressor, will be sold in latex-free 5 mg per 5mL vials. According to the American Heart Association, an estimated 1.4 million people annually suffer a heart attack or AMI. IMS data indicates 2009 sales of Metoprolol approximated $13 million. This is expected to be launched shortly, the company said in a press release.
Metoprolol is the sixth product being launched under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the US market which will be marketed by Sagent.
Ravi Seth, chief executive officer, international operations of Strides said, "The approval from USFDA, a third product within last 10 days, reflects the strong development capabilities of Strides. This is an important addition to cardiovascular care portfolio of the partnership with Sagent, which already includes Adenosine vials and Labetlol vials, and has received 7 ANDA approvals till date."
