FDA Approves 39 New Drugs in 2012

First New Tuberculosis Drug Approval in Four Decades

Yahoo Contributor Network

Both pharmaceutical companies and officials at the U.S. Food and Drug Administration have been busy -- the drug companies compiling statistics from clinical research trials and the FDA going through its vetting process to ensure the safety and efficacy of proposed new medications. The most recently approved medication, Sirturo, was developed for the treatment of multi-drug resistant tuberculosis, MDR-TB, an infection rarely seen in the United States but prevalent in China, Eastern Europe, Russia and India.

FDA 2012 Approval Numbers

In the last 20 years, the greatest number of new approvals occurred in 1996 when 53 new medications were added to the marketplace. In 1997, 39 new drugs met FDA approval. Approvals slowed for some years until 2004 when 36 approvals were awarded by the FDA, then slowed again until the 39 approvals in 2012.

Newest Tuberculosis-Fighting Drug Fast-Tracked by FDA for Approval

Johnson & Johnson's drug Sirturo, or bedaquiline, intended for the treatment of drug-resistant strains of tuberculosis, received a speedy go-ahead to market, a process used by the FDA when preliminary clinical research demonstrates positive results.

Tuberculosis, caused by bacteria that most often affects the lungs, is rarely seen in the United States but is rampant in other areas of the world. As many as 1.4 million people die worldwide annually from the illness, with approximately 150,000 of those deaths from MDR-TB.

Sirturo, the first new anti-tuberculosis drug to market in more than 40 years, is not without its concerns. Designed to be used in conjunction with the older anti-tuberculosis medications, Sirturo carries a boxed warning on its label that it can interfere with the heart's electrical system, something that could result in fatal arrhythmia .

Bedaquiline is not intended as a first line of defense against tuberculosis infection, but rather when all other available treatments have been ineffective. Left unabated, the tuberculosis could lead to death and at that point in the illness health care providers would need to weight the possible side effects of a medication that could save the person's life by clearing the infection.

New Medications Approved by FDA in 2012

The FDA provides a listing of new and generic drugs the agency approved in 2012. Drugs in the listing include Eliquis, a blood thinner for people with atrial fibrillation not related to a heart valve problem; Juxtapid, an anti-cholesterol medication for people with an uncommon genetic disorder affecting LDL cholesterol levels; and Iclusig, another medication that received fast-track approval, for the treatment of two rare types of leukemia. Thirty-six other drugs also received approval.

Bottom Line

The discovery and clinical research that are behind each new drug is often long, arduous and expensive. MedCityNews.com reported that major pharmaceutical companies took a big financial hit in 2012 due to patents expiring on many large money-making medications, with cheaper generic drugs taking up the slack to the tune of $21 billion for U.S. drug makers and $10 billion for European drug makers.

As difficult as it can be to feel sympathy for the drug companies, the truth is manufacturing and distributing medications is a business. If profits fall too much, it is difficult to fund the discovery and research phases for potential new cures.

Everyone, from infants to baby boomers to centenarians, benefits from the continued science of pharmacy.

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