Lupin Gets CDSCO Panel Nod to Study FDC of Fluticasone, Glycopyrronium, Vilanterol Inhalation Powder
New Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed-dose combination (FDC) of the pulmonary drug Fluticasone Furoate plus Glycopyrronium Bromide plus Vilanterol Trifenatate Inhalation Powder.
This came after the drug major Lupin presented the Phase IV clinical trial protocol before the committee.
Phase IV trials are conducted as postmarketing efforts to further evaluate the characteristics of the new drug with regard to safety, efficacy, new indications for additional patient populations, and new formulations.
Fluticasone Furoate is used in the treatment of sneezing and runny nose due to allergies. Fluticasone Furoate is a steroid that works by blocking the production of certain chemical messengers in the body that cause inflammation (redness and swelling) and allergies.
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