FDA extends Menactra’s age approval
WASHINGTON The Food and Drug Administration has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10.
The FDA originally approved Menactra back in 2005 for people aged 11 to 55. Now, Menactra joins Menomune as the only vaccines available for children aged 2 and older. Sanofi Pasteur manufactures both drugs.
Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain. It can result in death or permanent injury to the brain and nervous system. In the United States, about 2,600 people become ill from bacterial meningitis annually. About 10 percent die from the infection and another 15 percent or so suffer brain damage or limb amputation.
Clinical trials of the drug in people ages 2 to 55 years showed that the vaccine produced an immune response one month after vaccination, with little side effects beyond pain at the injection site and irritability.
FDA approves label changes for Accutane and its generics
The Food and Drug Administration has approved label changes to Roche’s acne medication Accutane and its generic isotretinoin, manufactured by Barr Laboratories, Genpharm/Mylan Pharmaceuticals and Ranbaxy Laboratories.
The label changes were made to improve the management of the iPledge pregnancy risk management program. Pregnant women are not allowed to take the medication due to risk of birth defects.
Roche, who proposed the changes, said they are intended to enhance the flexibility of the iPledge program, reduce interruptions in treatment and reduce the burden on patients, prescribers and pharmacies, thereby making the program more consistent with the way prescribers function.
The changes are planned to go into effect on Dec. 2.
FDA approves Ixempra for breast cancer
WASHINGTON The Food and Drug Administration has approved Bristol-Myers Squibb’s Ixempra monotherapy for the treatment of patients with metastatic or locally advanced breast cancer whose tumors are resistant or refractory to anthracyclines, taxanes and capecitabine.
The FDA has also granted approval of Ixempra in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to an anthracycline and a taxane or whose cancer is taxane-resistant and for whom further anthracycline therapy is contraindicated.
BMS anticipates Ixempra will be available soon.