FDA OKs urinary infection injectable drug

Oct 18, 2007

The U.S. Food and Drug Administration announced approval Thursday of doripenem (Doribax) injections for the treatment of complex urinary tract infections.

The 500 mg intravenous infusion, also used to treat intra-abdominal infections, have been shown to be active against several strains of bacteria, the FDA said.

"This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections," said Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs.

Officials said doripenem, in several multi-center, multinational studies, was shown to have a cure rate comparable to the currently prescribed medications levofloxacin, used for complicated urinary tract infections, and meropenem, indicated for complicated intra-abdominal infections.

However, the FDA said the safety and effectiveness of doripenem injection in pediatric patients and pregnant women has not been established.

Doripenem injection is manufactured under the brand name Doribax by Johnson and Johnson Pharmaceutical Research and Development LLC of Raritan, N.J.

Copyright 2007 by United Press International

Explore further: EU regulator: Morning-after pill OK for all women

add to favorites email to friend print save as pdf

Related Stories

'Shocking' underground water loss in US drought

28 minutes ago

A major drought across the western United States has sapped underground water resources, posing a greater threat to the water supply than previously understood, scientists said Thursday.

Study shows role of media in sharing life events

1 hour ago

To share is human. And the means to share personal news—good and bad—have exploded over the last decade, particularly social media and texting. But until now, all research about what is known as "social sharing," or the ...

The microbes make the sake brewery

1 hour ago

A sake brewery has its own microbial terroir, meaning the microbial populations found on surfaces in the facility resemble those found in the product, creating the final flavor according to research published ahead of print ...

New approach to form non-equilibrium structures

1 hour ago

Although most natural and synthetic processes prefer to settle into equilibrium—a state of unchanging balance without potential or energy—it is within the realm of non-equilibrium conditions where new possibilities lie. ...

Recommended for you

EU regulator: Morning-after pill OK for all women

7 hours ago

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

12 hours ago

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

Zydelig approved for three types of blood cancer

12 hours ago

(HealthDay)—Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) ...

Journal raises concern about blood-thinning drug

Jul 23, 2014

A medical journal raised concerns Wednesday about a blood-thinning drug widely used by people at risk of stroke, accusing its manufacturer of concealing safety data and regulators of laxness.

User comments : 0