Glyrx-Pf

Reduces salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and…. NDA 210997, held by Exela Pharma. Glycopyrrolate.

As of Nov 13, 2026, NDA 210997 (Glyrx-Pf), held by Exela Pharma, was first approved by FDA on Jul 11, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 11, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GLYRX -PF is indicated: in anesthesia (all ages)

for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,
intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias
for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jul 16, 2025	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 11, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label
Jul 11, 2018	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Letter Label

Products

4 strengths and forms

Product	Active ingredient	Marketing
Glyrx-Pf0.2MG/ML (0.2MG/ML) · solution;intramuscular, intravenous	Glycopyrrolate	DiscontinuedReference drug
Glyrx-Pf0.4MG/2ML (0.2MG/ML) · solution;intramuscular, intravenous	Glycopyrrolate	RxReference drug
Glyrx-Pf1MG/5ML (0.2MG/ML) · solution;intramuscular, intravenous	Glycopyrrolate	RxReference drug
Glyrx-Pf0.6MG/3ML (0.2MG/ML) · solution;intramuscular, intravenous	Glycopyrrolate	DiscontinuedReference drug

Identifiers

Application: NDA 210997
Drugs@FDA: Overview at FDA
Company: Exela Pharma Sciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters