On November 01, 2022, Alembic Pharmaceuticals Limited (Alembic) said it has received final approval from the US health regulator (US Food and Drug Administration) for its generic version of Glycopyrrolate injection USP used as a pre-operative medicine in order to inhibit salivary gland and respiratory secretions.
This approval by the US Food and Drug Administration is for the Abbreviated New Drug Application (ANDA) for Glycopyrrolate injection USP.
This approval is typically for the Glycopyrrolate strengths:
1. 0.2 mg/1mL & 0.4 mg/2mL (0.2 mg/mL) single-dose vials
2. 1 mg/5mL (0.2 mg/mL) & 4 mg/20 mL (0.2 mg/mL) multiple-dose vials
This is the first injectable medicinal product approved from the general sterile facility (F-3) which was inspected back in August 2022.
The approved Abbreviated New Drug Application is therapeutically equivalent to the RLD (Reference listed drug) product, of Hikma Pharma USA Inc. (Hikma).
Glycopyrrolate Injection USP is authorized for use as a preoperative antimuscarinic in order to reduce salivary, tracheobronchial, and pharyngeal secretions. The drug is used to scale down the volume and free acidity of gastric secretions. Additionally, it is used to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.
When indicated, this medicinal product may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated with arrhythmias.
Glycopyrrolate is effective against the peripheral muscarinic effects (bradycardia and excessive secretions) of cholinergic agents such as pyridostigmine and neostigmine gave to reverse the neuromuscular blockade because of the non-depolarizing muscle relaxants.
The medicine is also indicated for use in adult patients as adjunctive therapy to treat peptic ulcers when the rapid anticholinergic effect is required or when oral medications can not be used/considered.
Stats: According to IQVIA, Alembic Pharmaceuticals said Glycopyrrolate Injection USP, had an estimated market size of 42 Million USD for twelve months ended June 2022.