Cipla receives USFDA final approval for Metoprolol ER Tablets

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Metoprolol ER Tablets 50mg, 100mg, 200mg from the United States Food and Drug Administration (US FDA).

Cipla's Metoprolol ER Tablets 50mg, 100mg, 200mg is AB-rated generic therapeutic equivalent version of Aralez Pharmaceuticals, Inc.'s, Toprol XL. It is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure, Angina Pectoris, heart failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.

According to IQVIA (IMS Health), Toprol XL and its generic equivalents had U.S. sales of approximately $464M for the 12-month period ending Aug 2018.

 

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