Caraco receives FDA approval for generic allergy drug

Cetirizine hydrochloride chewable, which will be marketed as two separate over-the-counter (OTC) products in two strengths, 5 mg and 10 mg, is an antihistamine drug, which is used to treat allergies, hives and other allergic inflammatory conditions. These new products are bioequivalent to children’s Zyrtec chewable tablets for allergy relief and children’s Zyrtec for hives relief, registered trademarks of Johnson & Johnson.

Daniel Movens, Caraco’s CEO, said: “We are extremely pleased to receive this FDA final approval for our second generic OTC product to be added to our current portfolio of prescription products. We feel that cetirizine hydrochloride chewable complements our previously announced FDA final approval of cetirizine hydrochloride tablets, 5mg and 10mg, and both products will be positive additions to our portfolio by expanding our product offerings. Children’s Zyrtec chewable tablets for allergy relief have just been approved for the OTC market and we are pleased to be able to market a generic OTC version as an alternative.”