Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Estradiol, Progesterone FDC soft gelatin capsule
New Delhi: Granting for Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to drug major Akum Pharmaceuticals for manufacturing and marketing the fixed-dose combination (FDC) drug Estradiol plus Progesterone (1mg+100mg) soft gelatin capsule.
This came after drug major Akum Pharmaceuticals presented the bioequivalence (BE) report of the proposed drug combination, along with justification for Phase III clinical trial waiver before the committee.
Estradiol has several functions in the female body. Its main function is to mature and then maintain the reproductive system. During the menstrual cycle, increased estradiol levels cause the maturation and release of the egg, as well as the thickening of the uterus lining to allow a fertilized egg to implant.
Progesterone is an endogenous steroid hormone that is commonly produced by the adrenal cortex as well as the gonads, which consist of the ovaries and the testes. Progesterone is also secreted by the ovarian corpus luteum during the first ten weeks of pregnancy, followed by the placenta in the later phase of pregnancy.
Estradiol and progesterone combination is used to treat moderate to severe symptoms of menopause (e.g., feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating [hot flashes]) in women with a uterus.
At the recent SEC meeting for reproduction and urology held on 30th August 2023, the expert panel reviewed the BE report along with the justification for the Phase III clinical trial waiver for the FDC Estradiol plus Progesterone capsule.
The committee noted that the said FDC is already approved in the US, Australia, UK, Canada, EU, etc.
After detailed deliberation, the committee considered the Phase III clinical trial waiver and recommended the grant of permission for manufacturing and marketing of the FDC with the condition of conducting the active post-marketing surveillance (PMS) study.
In accordance with the above, the expert panel suggested that the firm should submit the active post-marketing surveillance (PMS) study protocol to CDSCO within 03 months of approval for review by the committee.
