Cipla gets final nod for generic version of Aralez's Toprol Xl ER tablets

Cipla's Metoprolol ER Tablets 50mg, 100mg, 200mg is AB-rated beta1-selective adrenoceptor blocking agent

Pharmaceutical major Cipla Ltd on Monday informed stock exchanges that it had received a 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,” the company said in its statement to BSE.

According to IQVIA (IMS Health), Toprol XL and its generic equivalents had US sales of approximately $464 million for the 12-month period ended August 2018.