Conduct Phase III CT of Triptorelin to treat chronic pain linked to endometriosis: CDSCO Panel Tells Dr Reddy's Lab
New Delhi: Citing that the pharmaceutical giant Dr. Reddy's Laboratories has not supplied data on the Indian population for the management and relief of chronic pain associated with endometriosis for the drug Triptorelin powder for injection 3.75mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the Phase III clinical trial of the Triptorelin powder for injection 3.75mg for the management and relief of chronic pain associated with endometriosis.
This came after the drug major Dr. Reddy's Laboratories presented its proposal for a grant of permission (additional Indication) for the management and relief of chronic pain associated with endometriosis for the drug Triptorelin powder for injection 3.75mg along with justification for Bio and clinical trial (CT) waiver before the Committee.
The Committee noted that the firm has not provided Indian population data for a proposed additional indication.
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