Unichem Labs allergic rhinitis drug gets tentative approval from USFDA

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.