Last Updated on October 17, 2024 by The Health Master
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for glycopyrrolate injection USP, 0.2 mg/1 ml and 0.4 mg/2 ml (0.2 mg/ml) single-dose vials, and 1 mg/5 ml (0.2 mg/ml) and 4 mg/20 ml (0.2 mg/ml) multiple-dose vials.
This is the first injectable product approval from the general sterile facility (F-3) of Alembic, which was inspected in August 2022.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) of Hikma Pharmaceuticals USA Inc.
Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
When indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated with arrhythmias.
Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
It is also indicated for use in adults as adjunctive therapy for the treatment of peptic ulcers when the rapid anticholinergic effect is desired or when oral medication is not tolerated.
Glycopyrrolate injection (USP) has an estimated market size of USD 42 million for the twelve months ending June 2022, according to IQVIA.
Alembic has a cumulative total of 173 ANDA approvals (149 final approvals and 24 tentative approvals) from the USFDA.
USFDA gives final approval for Mesalamine extended-release capsules
USFDA gives final approval for Paclitaxel injection
USFDA gives approval to this Blood Cancer therapy
USFDA grants final approval for Micafungin for injection
USFDA gives tentative approval for Valbenazine capsules
USFDA gives nod for Extended Phenytoin Sodium Capsules
NPPA panel recommends retail price fixation for Atorvastatin and Bempedoic acid
USFDA gives final approval for Mesalamine extended-release capsules
NPPA fixes price of 272 new drugs in the first six months of 2022-23
Govt constitutes 7 member panel to prepare ‘National Drugs Database’
DCGI to SDCs: Accept hard copy of application for registration of Medical Devices
USFDA issues Form 483 with 5 observations to Lupin
IPC introduces draft amendment to microbial contamination in IP 2022
USFDA issues Form 483 with one Observation to Laurus Labs
CDSCO Panel approves Tofacitinib Ointment 2% to Continue Clinical Trial Study
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
