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).
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