Unichem Labs gets tentative USFDA nod for generic version of JnJ Zyrtec-D 12 Hour
Unichem Lab's approved drug is a generic copy of Zyrtec-D 12 Hour which is used for treating allergic rhinitis.
New Delhi: Unichem Laboratories Tuesday said it has received tentative approval from the US health regulator for its generic copy of allergic rhinitis Johnson & Johnson Consumer Inc's Zyrtec-D 12 Hour used for treating allergic rhinitis.
The tentative nod by the US Food and Drug Administration (USFDA) is for the company's Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride extended-release tablets, 5 mg/120 mg, Unichem Laboratories said in a regulatory filing.
The over the counter product is also indicated as a nasal decongestant.
The product will be commercialised from Unichem's Goa plant on receipt of final approval, it added.