Submit additional data: CDSCO Tells Laurus Labs to on Carglumic acid dispersible tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major Laurus Labs conduct the bioequivalence (BE) study of Carglumic acid 200mg dispersible tablets and submit the additional report along with additional data with respect to the orphan drug status in the United States and Europe and published clinical trial data.
This came after Laurus Labs presented the revised bioequivalence study protocol along with a Phase III clinical trial waiver in the country for the grant of permission to manufacture and market the Carglumic acid 200mg dispersible tablets before the committee.
Carglumic acid is used to treat the severe hyperammonemia that occurs in the urea cycle disorder caused by a deficiency of hepatic N-acetyl glutamate synthase (NAGS) which normally produces N-acetyl glutamate. Hyperammonemia is a metabolic condition characterized by raised levels of ammonia, a nitrogen-containing compound.
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