DOW JONES NEWSWIRES 
 

Centocor Ortho Biotech Products LP, a unit of Johnson & Johnson (JNJ), received a complete response letter from the Food and Drug Administration regarding the company's supplemental new drug application for the use of Doxil in a combination therapy for advanced breast cancer.

In July, an FDA committee made a nonbinding recommendation indicating the combination with docetaxel didn't provide a sufficient benefit for its risk.

On Thursday, Centocor, which markets the drug in the U.S., said it is evaluating the letter and will respond as quickly as possible. The company filed the application a year ago for the drug, which is already used to treat other cancers.

The drug carries a boxed warning that alerts users to possible cardiac toxicity and liver impairment, as well as other potential side effects.

Janssen-Cilag markets the drug in Israel, while Schering-Plough Corp. (SGP) markets it as Caelyx in the rest of the world, except for Japan and Israel.

Johnson & Johnson shares were unchanged at $60.66 in after-hours trading.

- By Jay Miller, Dow Jones Newswires; 212-416-2355; jay.miller@dowjones.com