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Unichem Labs allergic rhinitis drug gets tentative approval from USFDA

The product will be commercialised from Unichem's Goa plant on receipt of final approval

Unichem Labs  |  Unichem Laboratories  |  Usfda

Press Trust of India  |  New Delhi 

Unichem Lab

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, 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.

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First Published: Tue, May 07 2019. 12:40 IST