Cipla receives final approval for generic version of Aralez Pharmaceuticals’ Toprol XL® ER Tablets

Deepthi | Myequity news | Date : 29-10-2018 09:30:00 IST

Cipla Limited (“Cipla”) today announced that it 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.


About Cipla:

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America and key regulated and emerging markets. Its strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Its 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.


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