Pfizer Gets CDSCO Panel Nod for Active PMS Study of FDC Levonorgestrel Plus Ethinyloestradiol Tablets

New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the active postmarketing surveillance (PMS) study of fixed-dose combination (FDC) Levonorgestrel 0.15 mg plus Ethinyloestradiol 0.03 mg tablets.

However, the expert panel stated that the result of the study should be submitted to CDSCO for review by the committee.

This came after Pfizer presented an active postmarketing surveillance (PMS) study protocol before the committee, as per the condition mentioned in Form CT-23 dated 18.12.2023.

Levonorgestrel/ethinyl estradiol is a combination birth control medicine used to prevent pregnancy in women. Levonorgestrel/Ethinyl estradiol contains 2 types of hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen).

Levonorgestrel, also known as the morning-after pill, is a first-line oral emergency contraceptive pill with approval from the World Health Organization to prevent pregnancy. It is FDA-approved to be used within 72 hours of unprotected sexual intercourse or when a presumed contraceptive failure has occurred.

Ethinylestradiol (EE) is an estrogen medication that is widely used in birth control pills in combination with progestins. In the past, EE was widely used for various indications, such as the treatment of menopausal symptoms, gynecological disorders, and certain hormone-sensitive cancers. It is usually taken by mouth but is also used as a patch and vaginal ring.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the active PMS protocol of the FDC Levonorgestrel plus Ethinyloestradiol.

After detailed deliberation, the committee recommended conducting an active PMS study. Furthermore, the committee added that the result of the study should be submitted to CDSCO for review by the committee.

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