Abbott gets CDSCO panel nod for importing, marketing of Estradiol, Dydrogesterone FDC

However, the SEC approval came with the condition that the firm should submit the Phase IV clinical trial protocol within 3 months of approval of the said FDC.

The nod came after the firm presented the trial data of said FDC of the Dydrogesterone plus Estradiol with respect to the Asian population. The trial data was presented in line with the earlier SEC recommendation dated 23.09.2020 where the drug maker, Abbott, was directed to present stratified data of the Asian population with respect to the efficacy and safety of the proposed FDC for further review by the committee.

Estradiol/dydrogesterone combination tablet is used in menopausal hormone therapy, specifically to treat and prevent hot flashes and osteoporosis, in postmenopausal women. The combination consists of hormones named estradiol and dydrogesterone.

Estradiol is a naturally occurring hormone circulating endogenously in females which acts by restoring the falling levels of estrogen in the body, helping to reduce distressing symptoms of menopause. It is commercially available in several hormone therapy products for managing conditions associated with reduced estrogen, such as vulvovaginal atrophy and hot flashes.

Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions.

However, Abbott sells the FDC Estradiol/dydrogesterone under the brand name Femoston Tablet, which has a salt composition of Estradiol (1mg) + Estradiol (1mg) + Dydrogesterone (10mg).

At the previous SEC meeting, the committee noted that the combipack of 28 tablets of Estradiol 1mg and Dydrogesterone 5mg was already approved by CDSCO on 23.11.2006.

Recently, at the 60th SEC meeting for Reproductive & Urology, held on 25.06.2021 & 28.06.2021, at CDSCO, the Committee thoroughly examined the proposal that presented the trial data of said FDC Dydrogesterone plus Estradiol with respect to Asian population.

After detailed deliberation, the committee considered the Phase III CT waiver and recommended grant of permission for import and market of the subject FDC subject to the condition that the firm should submit the Phase IV clinical trial protocol within 3 months of approval of the FDC.