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CDSCO panel tells Glenmark to provide in-vivo data, global data concerning Pulmonary FDC in inhalation suspension
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Overview
In reaction to the request for a waiver of bioequivalence (BE) and Phase III clinical trials for the inhalation suspension of the pulmonary drug combination Glycopyrrolate, Formoterol Fumarate Dihydrate, and Budesonide (25mcg+20mcg+500mcg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the drug major Glenmark Pharmaceuticals to provide both in-vivo study data and global data concerning the Fixed-Dose Combination (FDC) in Inhalation Suspension dosage form.
For more details, check out the link given below:
Speakers
Roshni Dhar, a Mass com graduate with a soft corner for health happenings, joined Medical Dialogues as a news anchor in 2021. Inspired by her mother who is a gynaecologist, she likes to keep herself and the world updated on the occurring in the medical field. She covers various aspects of health news for MDTV at Medical Dialogues. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751