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Strides Arcolab Gets FDA Nod For Metoprolol Tartrate Injection

Strides Arcolab (Strides) has received 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 Tartrate is the sixth product being launched under the Strides and Sagent Pharmaceuticals partnership.

Metoprolol is the generic equivalent of Novartis pharmaceutical’s Lopressor (Metoprolol Tartarate injection, USP). It 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. The drug will be sold in latex-free 5mg per 5ml vials.

Ravi Seth, CEO of international operations at Strides, said: “We are delighted with the receipt of the third product approval from the FDA within 10 days which reflects the 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 7 ANDA approvals till date.”