CDSCO Panel Asks Dr Reddy's to Submit Indian Data for Triptorelin Pediatric Use
New Delhi: The Subject Expert Committee (SEC) under the Endocrinology and Metabolism division of the Central Drugs Standard Control Organisation (CDSCO) has withheld approval for Dr Reddy's Laboratories Limited's proposal to import and market Triptorelin Powder for Injection 22.5 mg for a pediatric indication, recommending that the firm first submit additional data on Indian population-specific studies and the unmet medical need before further consideration.
The Panel evaluated a proposal submitted by Dr. Reddy's seeking permission to import and market Triptorelin Powder for Injection 22.5 mg for an additional pediatric indication.
The company applied for approval to use Triptorelin in the treatment of confirmed central precocious puberty (CPP) in children aged 2 years and above — specifically for girls with onset before age 8 and boys before age 9. The proposal also included a request for a waiver of local clinical trials.
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