This site is intended for Healthcare professionals.
×

Unichem Laboratories gets USFDA nod to market BP drug Chlorthalidone tablet

................................ Advertisement ................................


business medical dialogues

Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.

The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing.

The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

................................ Advertisement ................................

Hygroton tablets are indicated in the management of hypertension, either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension, Unichem Laboratories said.

Read Also: Unichem Labs gets 4 USFDA observations for Goa formulation facility

................................ Advertisement ................................

It is also used as an adjunctive therapy in edema, associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy and the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Unichem said the product will be commercialized from its Ghaziabad plant.

................................ Advertisement ................................

Read Also: Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour

Spread the love

Author Details

Medical Dialogues Bureau

Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

Source: PTI
0 comment(s) on Unichem Laboratories gets USFDA nod to market BP drug Chlorthalidone tablet

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted

    ................................ Advertisement ................................