Unichem Labs bags USFDA nod for Labetalol Hydrochloride Tablets
Mumbai: Drugmaker, Unichem Laboratories Limited, has recently announced that the company has received Abbreviated New Drug Application (ANDA) approval for its Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg, and 300 mg from the United States Food and Drug Administration (USFDA).
The product is a generic version of NORMODYNE (Labetalol Hydrochloride) Tablets 100 mg, 200 mg and 400 mg, of SCHERING CORP SUB SCHERING PLOUGH CORP.
Labetalol Hydrochloride Tablets are indicated for the management of hypertension.
The product will be commercialized from Unichem's Goa Plant.
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Blood pressure is the force exerted by circulating blood against the walls of the body's arteries, the major blood vessels in the body. Hypertension is when blood pressure is too high.
Blood pressure is written as two numbers. The first (systolic) number represents the pressure in blood vessels when the heart contracts or beats. The second (diastolic) number represents the pressure in the vessels when the heart rests between beats.
Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
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