CDSCO panel tells Glenmark to provide in-vivo data, global data concerning Pulmonary FDC in inhalation suspension
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:
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd