Aurobindo Pharma has received the final approval for Cetirizine Hydrochloride syrup 1mg/ml from the FDA. The approval of Cetirizine Hydrochloride syrup is under the prescription drug product category.
Certirizine Hydrochloride syrup of 1mg/ml is the generic equivalent of McNeil Consumer Healthcare Zyrtec syrup 1mg/ml.
Cetirizine Hydrochloride syrup is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children above 2 years of age and falls under anti-allergic segment.
Aurobindo has a total of 110 ANDA approvals from the FDA.
Cetirizine hydrochloride is an orally active and selective H1-receptor antagonist. The chemical name is (±) – [2- [4- [ (4-chlorophenyl) phenylmethyl] -1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride syrup is a colorless to slightly yellow syrup containing cetirizine hydrochloride at a concentration of 1mg/ml (5 mg/5ml) for oral administration.
Cetirizine was rapidly absorbed with a time to maximum concentration (Tmax) of approximately 1 hour following oral administration of tablets or syrup in adults. Comparable bioavailability was found between the tablet and syrup dosage forms.