Lupin Gets CDSCO Panel Nod to Study Antidiabetic FDC
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-11-01 12:30 GMT | Update On 2024-11-01 12:30 GMT
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New Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) antidiabetic drug, Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin plus Metformin HCl IP (extended-release) (10mg+100mg+1000 mg/25mg+100mg+1000mg) film coated bilayered tablets.
However, this nod is subject to the condition that the trained physician (MD, Internal Medicine) be present during the study.
This came after drugmaker Lupin presented the proposal along with a BE study protocol before the committee. Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product.
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