FDA grants additional market exclusivity to Eisai GERD drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.
Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.
Still, the decision does not mean the drug is approved for use in children, Eisai said. The drug maker has an approval application pending before the FDA for Aciphex delayed-release sprinkle capsules in the 5-mg and 10-mg strength for GERD in children aged 1 to 11, and the FDA expects to complete its review by Nov. 27, 2013.
Reports: Congressional committee looking into compounding industry group’s practices
NEW YORK — A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.
Reuters reported that the House Energy and Commerce Committee had requested internal documents from the International Academy of Compounding Pharmacists, citing a news report about the organization.
The request comes amid a nationwide meningitis outbreak linked to contaminated supplies of steroid drugs prepared at the New England Compounding Center that had sickened 541 people and killed 36 in 19 states as of Monday, according to the Centers for Disease Control and Prevention.
FDA approves new indication for J&J prostate cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.
The FDA announced the approval of Zytiga (abiraterone acetate), made by J&J subsidiary Janssen Biotech, for men with castration-resistant prostate cancer that has spread to other parts of the body, for use prior to receiving chemotherapy. The drug was already approved for castration-resistant prostate cancer in men who had already undergone chemotherapy treatment.
In castration-resistant prostate cancer, the cancer cells continue to grow even when men have undergone drug treatment or surgery to block testosterone, which stimulates the growth.
"Today’s approval demonstrates the benefit of further evaluation a drug in an earlier disease setting and provides patients and healthcare providers the option of using Zytiga earlier in the course of treatment," FDA Office of Oncology Drug Products director Richard Pazdur said.