Conduct BE study and clinical trial: CDSCO Panel tells Cipla on Formoterol Fumarate Dihydrate, glycopyrronium inhaler
New Delhi: Rejecting the proposal for clinical trial and bioequivalence (BE) study waiver presented by drug major Cipla, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the BE study of the fixed-dose combination Formoterol Fumarate Dihydrate plus Glycopyrronium inhaler with innovator product as a reference product.
In addition, the expert panel rejected the clinical trial waiver at this stage.
This came after the drug major Cipla presented their proposal along with justification for clinical trial and bioequivalence (BE) study waiver before the committee.
Formoterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
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