Mylan Pharmaceutical Gets CDSCO Panel Nod To study Selatogrel
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-03-11 11:30 GMT | Update On 2025-03-11 11:30 GMT
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New Delhi: Mylan Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study of Selatogrel 16mg/0.5mL aqueous solution.
This came after the firm presented phase 3 clinical study protocol no.: ID-076A301 version: 5.0dated 09 June 2023. This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction.
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