Orbactiv approved for drug-resistant skin infections

(HealthDay)—The antibacterial drug Orbactiv (oritavancin) has been approved by the U.S. Food and Drug Administration to treat drug-resistant skin infections in adults, the agency said in a news release.

The drug is sanctioned to treat methicillin-resistant Staphylococcus aureus (MRSA) and other acute bacterial . It's the third such drug approved in 2014, following May approval of Dalvance (dalbavancin) and June approval of Sivextro (tedizolid), the FDA said.

Orbactiv's safety and effectiveness were evaluated in two clinical studies involving almost 2,000 adults. The most common side effects included headache, nausea, vomiting, skin abscesses on the arms and legs, and diarrhea.

The drug's label will include a boxed warning that it could interact with the blood-thinning medication warfarin, the agency said.

Orbactiv is marketed by The Medicines Company, based in Parsippany, N.J.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Sivextro approved for adult skin infections

Jun 23, 2014

(HealthDay)—The antibiotic Sivextro (tedizolid phosphate) has been approved by the U.S. Food and Drug Administration to treat adults with skin infections.

Impavido approved to treat tropical parasitic disease

Mar 20, 2014

(HealthDay)—Impavido (miltefosine) has been approved by the U.S. Food and Drug Administration to treat adults with leishmaniasis, a tropical disease caused by a parasite that's transmitted by the bites of sand flies.

Zydelig approved for three types of blood cancer

Jul 24, 2014

(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) ...

Iclusig approved for rare leukemias

Dec 16, 2012

(HealthDay)—Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

Recommended for you

Ebola vaccine not before late 2016: GSK researcher

Oct 17, 2014

An Ebola vaccine by British pharmaceuticals giant GlaxoSmithKline may not be ready for commercial use until late 2016 and should therefore not be seen as the "primary answer" to the current outbreak, a company researcher ...

Chimerix gets FDA OK to test drug for Ebola

Oct 17, 2014

(AP)—A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration.

Esbriet, ofev approved to treat deadly lung disease

Oct 16, 2014

(HealthDay)—Two new drugs have been approved by the U.S. Food and Drug Administration to treat progressive lung scarring from an uncertain cause, medically called idiopathic pulmonary fibrosis (IPF).

FDA weighs removing bolded warning from Chantix

Oct 14, 2014

(AP)—The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not ...

Drug-coated balloon catheter approved

Oct 13, 2014

(HealthDay)—The first drug-coated balloon catheter designed to clear narrowed or blocked arteries in the thigh and knee has been approved by the U.S. Food and Drug Administration.

User comments