Unichem Laboratories receives tentative USFDA nod for sales of allergy drug

Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s Zyrtec-D 12-hour Extended tablets.

A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug.

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release tablet is a combination drug used to relieve allergy symptoms such as watery eyes, runny and stuffy nose, itching eyes and nose and sneezing.

Cetirizine is an antihistamine and works by blocking a certain natural substance called histamine that the body makes during an allergic reaction.

Pseudoephedrine is a decongestant and works by narrowing blood vessels in the nose to decrease swelling and congestion.

Unichem said that the drug, in doses of 5 mg and 120 mg, will be manufactured at its facility in Goa after receiving a final approval from the USFDA.

Headquartered in Mumbai, Unichem has operations in Roha in Maharashtra, Goa, Baddi in Himachal Pradesh, Pithampur in Uttar Pradesh, Ghaziabad and Sikkim.

It is known for sales of generic drugs across the world.