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news.KV Pharmaceutical Company has received final approval from the FDA of its abbreviated new drug application to market its 50mg strength of metoprolol succinate extended-release tablets.
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The company expects to begin shipping immediately. This product is a generic version of AstraZeneca’s branded product, Toprol-XL. Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension used alone or in combination with other antihypertensive agents, for the long-term treatment of angina pectoris and for the treatment of stable, symptomatic heart failure of ischemic, hypertensive, or cardiomyopathic origin.
As a result of the 50mg approval, KV is now offering the complete line of all four dosage strengths of metoprolol succinate extended-release tablets, 200mg, 100mg, 50mg and 25mg. Based on the company’s first-to-file status on its abbreviated new drug application for these two strengths, KV was accorded the benefit of a 180-day generic exclusivity period for the marketing of these two dosage strengths.