Taro Pharmaceutical Industries Ltd has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cetirizine hydrochloride tablets (OTC). Cetirizine Tablets are approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. The tablets will be available in 5 mg and 10 mg strengths. The Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare’s Zyrtec®.

Novartis has received the FDA approval for its Tekturna HCT tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna, the first and only approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), a commonly used high blood pressure medication. Tekturna HCT is available in four strengths as tablets containing aliskiren and hydrochlorothiazide: 150mg/12.5mg tablets, 150mg/25mg tablets, 300mg/12.5mg tablets and 300mg/25mg tablets.

Mylan Pharmaceuticals has received approval from the FDA for its abbreviated new drug application (NDA) for liothyronine sodium tablets USP. The drug will be available in the strengths of 5mcg, 25mcg and 50mcg. Liothyronine sodium tablets are the generic version of King Pharmaceuticals’s treatment for thyroid deficiency, Cytomel. The company has started the shipping of the product.

The FDA has approved Teva Pharmaceuticals’ hGH needle-free injection, relieving kids requiring medication to enhance their human growth hormone (hGH) levels from fright and pain of shots. Needle-free injectors boost a fine stream of medicated liquid through the skin to the subcutaneous fatty tissue. This liquid is then absorbed by the body.

The FDA has issued a warning for the anti-smoking drugs Chantix and Zyban as bizarre behavior, including suicide, has been seen in people taking these medicines. Both drugs will now carry “black box” labels warning informing people that those consuming these drugs should be closely watched for signs of suicidal thoughts, depression, hostility or other changes in behavior.