New Delhi: Responding to the proposal presented by Mankind for the grant of permission to manufacture and market Dydrogesterone Injection 5mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit Phase-I/Phase-II clinical trial data, including pharmacokinetics/pharmacodynamic (PK/PD) study data, to establish a safe and effective dose in the IM (intramuscular) route.
This came after the firm presented the proposal for a grant of permission to manufacture and market Dydrogesterone injection 5mg/ml (Additional Dosage form) along with Phase-III clinical trial protocol before the committee.
The firm informed that the formulation Dydrogesterone injection 5mg/ml is not yet approved anywhere in the world. The firm also presented 28 repeated dose intramuscular toxicity data in female Wistar rat and Female New Zealand White rabbits.
Dydrogesterone is a progestin, or a synthetic progestogen, and hence is an agonist of the progesterone receptor, the biological target of progestogens like progesterone. The medication is an atypical progestogen and does not inhibit ovulation.
Dydrogesterone is used in female infertility, pain during menstruation, Premenstrual syndrome (PMS) and endometriosis. Dydrogesterone contains progestin (female hormone) that plays a major role in regulating the menstrual cycles in females. It initiates the normal, regular growth as well as shedding of the womb lining.
At the recent SEC meeting for Reproductive, the expert panel reviewed the proposal for grant of permission to manufacture and market dydrogesterone injection 5 mg/mL (Additional Dosage Form) along with Phase-III clinical trial protocol before the committee.
After detailed deliberation, the committee opined that the firm should submit Phase-I/Phase-II clinical trial data, including PK/PD study data to establish a safe and effective dose in IM (intramuscular) route, to CDSCO for further review by the committee.
Further, the expert panel suggested that animal toxicity data shall be carried out in accordance with para 2 of the second schedule of the New Drugs and Clinical Trials Rules (ND and CT).
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