Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure

  • By IPP Bureau | January 13, 2025

Senores Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP, 50 mg/25 mg and 100 mg/25 mg.

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

According to IQVIA and Symphony sales data for the 12-month period ending November 2024, the Metoprolol Tartrate and Hydrochlorothiazide Tablet USP, 50 mg/25 mg and 100 mg/25 mg market achieved annual sales of approximately $6 million and $10 million respectively.

Senores' current portfolio includes 24 ANDA products that are permitted for distribution in the USA. In addition to these internal filings, Senores is actively seeking external development collaborations to augment and accelerate the growth of its existing pipeline and portfolio.

“We have been relentlessly working in enhancing our product portfolio, which includes a wide range of specialty and complex pharmaceutical products across various therapeutic areas in regulated markets, particularly in the US. Metoprolol Tartrate and Hydrochlorothiazide are specialized formulations with limited competition in the US, providing us an opportunity to capture a higher market share in this region,” stated Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited.

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