Submit data on prevalence and genetic polymorphism of disease: CDSCO Panel Tells Dr Reddy's Laboratories on Siponimod tablet
New Delhi:In response to the proposal presented by the drug major Dr Reddy's Laboratories to manufacture and market the neurodrug Siponimod tablets 0.25 mg, 1 mg, and 2 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the data on prevalence and the genetic polymorphism of the disease secondary progressive multiple sclerosis.
This came after Dr. Reddy's Laboratories presented a proposal for a grant of permission to manufacture and market new drug Siponimod tablets 0.25 mg, 1 mg, and 2 mg, along with the bioequivalence (BE) study report of higher strength, i.e., 2 mg, and requested a local Phase-III clinical trial waiver and bioequivalence waiver for lower strength before the committee.
Siponimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
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