Strides Arcolab has received the approval for its Abbreviated New Drug Application (ANDA) to Market Metoprolol Tartrate injection, USP (Metoprolol) commonly used in the treatment of acute myocardial infarction (AMI).
Metoprolol will be sold in latex-free 5 mg per 5 mL vials. According to the American Heart Association, an estimated 1.4 million people annually will suffer a heart attack or AMI. IMS data indicates 2009 sales of Metoprolol approximated US$ 13 million. This is expected to be launched shortly.
According to Ravi Seth, chief executive officer, International Operations, Strides Arcolab, stated, “We are delighted with the receipt of the third product approval from the US FDA within 10 days which 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 Labetalol vials, and has received seven ANDA approvals till date.“
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. The drug is the generic equivalent of Novartis Pharmaceutical Corporation’s Lopressor (Metoprolol Tartrate Injection, USP). Metoprolol is a selective beta1-adrenoreceptor blocking agent that is indicated in the treatment of hemodynamically stable patients with definite or suspected AMI to reduce cardiovascular mortality. Treatment with intravenous Metoprolol can be initiated as soon as the patient’s clinical condition allows. Alternatively, treatment can begin within 3 to 10 days of the acute event.