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Last Updated : May 07, 2019 12:51 PM IST | Source: PTI

Unichem Laboratories gets USFDA tentative nod for allergic rhinitis drug

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


Unichem Laboratories on May 7 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.

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

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First Published on May 7, 2019 12:42 pm
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