Torrent pharma gets CDSCO nod to market additional strength of Amlodipine,Olmesartan Medoxomil FDC

Upon hydrolysis, olmesartan medoxomil is converted to olmesartan. Olmesartan selectively binds to the angiotensin type 1 (AT1) receptor of angiotensin II in vascular smooth muscle and the adrenal gland, thereby competing with angiotensin II binding to the receptor. This prevents angiotensin II-induced vasoconstriction and decreases aldosterone production, thereby preventing aldosterone-stimulated sodium retention and potassium excretion.

In individuals with mild to severe hypertension, a combination of olmesartan and amlodipine was considerably more effective than monotherapy in lowering blood pressure and meeting guideline blood pressure targets.

At a recent SEC meeting for Cardiovascular and Renal, the drug-maker presented their proposal before the committee along with their request for a Phase III clinical trial waiver for the manufacturing and marketing of the additional strength of a fixed dose combination drug consisting of Amlodipine Besylate USP eq. to Amlodipine 10mg plus Olmesartan Medoxomil USP 40mg Tablet.

The committee noted that the FDC is already approved by CDSCO at lower strength and the proposed FDC is already approved in the USA. The firm also presented the BE study report before the Committee.

After detailed deliberation, the committee recommended the grant of permission for manufacturing and marketing of the additional strength of the FDC.