Cipla gets FDA nod for generic Toprol

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Cipla gets FDA nod for generic Toprol

Cipla has received the Food and Drug Administration’s OK for metoprolol extended-release tablets in 50-mg, 100-mg and 200-mg dosage strengths.

Cipla’s Metoprolol ER tablets 50 mg, 100 mg, 200 mg are the generic of Aralez Pharmaceuticals’ Toprol XL.

The product is a beta1-selective adrenoceptor blocking agent.

Metoprolol succinate extended-release tablets are indicated to treat hypertension, angina pectoris, heart failure. It also is indicated to treat stable, symptomatic — NYHA Class II or III — heart failure of ischemic, hypertensive, or cardiomyopathic origin, the company said.

Toprol XL and its generic equivalents had a market value of approximately $464 million for the 12-month period ended August 2018, according to IQVIA data.

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