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Unichem Labs gets USFDA tentative nod for allergic rhinitis drug

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The company got the US health regulator’s nod for its Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride extended-release tablets

Unichem Laboratories has received tentative approval from the USFDA for its generic copy of, Johnson & Johnson Consumer’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 the final approval, the company disclosed.

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