Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution
New Delhi: The pharmaceutical major Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) for conducting Phase III clinical trials of Revefenacin Inhalation Solution 175 mcg/3 ml.
This came after the drug major Cipla presented the proposal for grant of permission to manufacture and market Revefenacin Inhalation solution 175 mcg/3ml along with a bioequivalence (BE) study waiver and phase III clinical trial protocol before the committee.
Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of the long-acting muscarinic antagonists (LAMA). The labile primary amide in the structure produces a "soft-drug" site that allows rapid systemic clearance and minimizes the systemically mediated adverse reactions.
Revefenacin is an inhaled bronchodilator muscarinic antagonist with a long-acting bronchodilation activity. It has been shown to present a high affinity and behave as a competitive antagonist of the five muscarinic cholinergic receptors.
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