Generics

ALLEGAN, Mich. — The Food and Drug Administration has granted market exclusivity for a generic version of a medication designed to treat indoor and outdoor allergies.

Perrigo said Monday that its licensor and supplier Synthon received regulatory approval for levocetirizine tablets, a generic version of UCB/Sepracor's Xyzal, which is marketed in the United States by Sanofi-Aventis.

The levocetirizine tablet is the only approved generic product having a label containing all indications, Perrigo said.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

DEERFIELD, Ill. — Walgreens' chief medical officer will discuss the evidence-based medicine design and impact of a diabetes management program delivered by pharmacists at both workplace and community pharmacies during an upcoming conference, the drug store chain said.

MUMBAI, India — A generic drug maker announced that the Food and Drug Administration has granted tentative approval for its version of a popular antidepressant.

Sun Pharmaceutical Industries said the FDA approved its duloxetine hydrochloride delayed-release capsules in 20-mg, 30-mg and 60-mg strengths. The capsules are a generic version of Eli Lilly's Cymbalta, which is indicated to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

MINNETONKA, Minn. — UnitedHealth Group will start a program next year that it said can reduce drug costs to as low as $2 per script, the company said Tuesday.

The program, Pharmacy Saver, will be available to Medicare Part D members and is a collaboration with Kroger, Safeway and Prescription Solutions. The program will allow members to purchase some scripts for $2 for 30- and some 90-day supplies and applies to hundreds of prescription drugs, including 8-of-the-10 most commonly used by UnitedHealthcare Medicare plan members.

ST. LOUIS — Since the beginning of the HIV/AIDS epidemic in the early 1980s, one of the greatest advances has been antiviral drugs that have helped extend the lives of patients with viral infections.

NEW YORK — A new study published in the Nov. 22 issue of Archives of Internal Medicine suggested there is a two-way relationship between depression and diabetes.