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news.Mylan Pharmaceuticals, a subsidiary of Mylan, has received final approval from the FDA for its abbreviated new drug application (ANDA) for Hydroxyzine Hydrochloride tablets 10mg, 25mg and 50mg.
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According to Mylan Pharmaceuticals, the product was determined to be bioequivalent and, therefore, therapeutically equivalent to Pliva’s Hydroxyzine Hydrochloride tablets, a treatment for nervousness and tension.Hydroxyzine hydrochloride sold under brand names: Vistaril, Atarax.
Atarax is an antihistamine used to relieve the symptoms of common anxiety and tension and, in combination with other medications, to treat anxiety that results from physical illness. It also relieves itching from allergic reactions and can be used as a sedative before and after general anesthesia.
Antihistamines work by decreasing the effects of histamine, a chemical the body releases that narrows air passages in the lungs and contributes to inflammation. Antihistamines reduce itching and swelling and dry up secretions from the nose, eyes, and throat.
Currently, Mylan has 138 ANDAs pending FDA approval.