LTC Bulletin Board - July 2011: Page 4 of 5

July 22, 2011

FDA Approves First Generic Versions of Levofloxacin

On June 20, 2011, the FDA announced it had approved applications from 12 manufacturers to produce the generic versions of Levaquin (levofloxacin) as a tablet, oral solution, and injectable (Table). Applications from several other manufacturers are still pending.

Levofloxacin, which is active against both gram-positive and gram-negative bacteria, is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate. It is also used to treat anthrax and certain respiratory infections, including bronchitis and community- and hospital-acquired pneumonia.

“Generic drugs are important options that allow greater access to health care for Americans,” said Keith Webber, PhD, deputy director, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, in an FDA statement. “FDA-approved generic drugs must meet rigorous standards and are required to be of high quality so that people can be assured that their medications will act the same in the body as the brand-name product.”

As a fluoroquinolone, levofloxacin carries the increased risk of tendinitis and tendon rupture. The risk is greater in adults ≥60 years of age, in patients taking corticosteroid drugs, and in those with kidney, heart, and lung transplants. The FDA warned, however, that the drug may also worsen muscle weakness in those with myasthenia gravis, a chronic autoimmune neuromuscular disease.


Policy News

New Act Yields Big Savings on Prescription Drugs

Approximately half a million people are receiving cheaper prescription drugs, thanks to the Affordable Care Act. In June 2011, the Centers for Medicare & Medicaid Services (CMS) announced that about 478,000 people with Medicare Part D who reached the coverage gap known as the “donut hole” received an automatic 50% discount on their covered brand-name prescription drugs. The beneficiaries received the discount in the first 5 months of 2011, resulting in total savings of $260 million, or an average savings of $545 per beneficiary. Most of the discounts are helping Americans with serious medical conditions. About $36 million was spent on cancer drugs, $21 million on drugs to control hypertension and cholesterol levels, and about $20 million on diabetes medications.

“Without the Affordable Care Act, many seniors and people with disabilities would pay twice as much for their prescription drugs in the donut hole,” said CMS Administrator Donald M. Berwick, MD, in a press release. In May 2011, the number of beneficiaries who received the discount rose by ≥76% and the dollar amount of savings rose by ≥56%. CMS expects that as many as 4 million more beneficiaries will fall into the coverage gap later this year and benefit from these discounts. An analysis from November 2010 by the U.S. Department of Health and Human Services estimated that Medicare improvements due to the Act would provide average per-person savings of more than $3500 over the next 10 years. Those with higher drug costs could see savings as high as $12,000.   

For more information about the drug discount and various provisions of the Affordable Care Act, visit