CDSCO Panel Recommends Phase IV Trial for Acne FDC Gel by Precise Biopharma
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New Delhi: The Subject Expert Committee (SEC) under the Dermatology and Allergy division of the Central Drugs Standard Control Organisation (CDSCO) has recommended to conduct Phase IV clinical trial for a fixed-dose combination (FDC) topical gel developed by Precise Biopharma Pvt. Ltd.
The formulation combines Clindamycin Phosphate IP 1.2% w/w (equivalent to Clindamycin 1% w/w) and Hydrous Benzoyl Peroxide IP (equivalent to anhydrous Benzoyl Peroxide 3.75%), a combination widely used in dermatological therapy for acne.
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