Cipla receives USFDA approval for Metoprolol ER tablets

Cipla has received a final approval from the USFDA for Abbreviated New Drug Application (ANDA) for Metoprolol ER Tablets 50mg, 100mg, 200mg. Shares of the company gained in early trade on Monday. 

Metoprolol ER Tablets 50mg, 100mg, 200mg is an 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.

Toprol XL and its generic equivalents had the US sales of approximately US$464M for the 12-month period ending August 2018 as per IQVIA (IIMS Health) data.

Cipla Limited strategic business units include Active Pharmaceutical Ingredients (APIs), Respiratory and Cipla Global Access. The company manufactures metered dose inhalers, dry powder inhalers, nasal sprays, nebulizers and a range of inhaled accessory devices. The company offers its products for therapeutic areas, including cardiovascular, children's health, dermatology and cosmetology, diabetes, HIV/AIDS, infectious diseases and critical care etc.

On Monday, the shares of the company opened at Rs. 604 per share against Friday’s close of Rs 603.45 on the BSE. At 10:45 hours, the share was trading at Rs.618.70 up by 2.53 per cent. The intraday high was Rs. 618.70 and intraday low was Rs. 602 per share on the BSE. Its 52-week high was Rs. 678 and 52-week low was Rs. 508.10 per share on the BSE. Meanwhile, BSE Sensex was at 33,579.93 level, up by 0.69 per cent.