Last Updated on December 31, 2023 by The Health Master
New Delhi: Approving the waiver of the phase 3 clinical trial, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted pharma major Torrent Pharmaceuticals the additional strength of fixed dose combination drug Amlodipine Besylate USP eq. to Amlodipine 10mg plus Olmesartan Medoxomil USP 40mg Tablet.
This came after drug-maker Torrent Pharmaceuticals presented their proposal before the committee along with their request for a Phase III clinical trial waiver.
Amlodipine is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers.
Amlodipine is commonly used in the treatment of high blood pressure and angina.
Amlodipine has antioxidant properties and the ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure.
Olmesartan Medoxomil is a synthetic imidazole derivative prodrug with an antihypertensive property.
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 a lower strength and that 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 the manufacturing and marketing of the additional strength of the FDC.
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