Caraco launches generic Trileptal
DETROIT Caraco Pharmaceuticals has launched a generic version of Novartis’ Trileptal, on behalf of Sun Pharmaceuticals, who recently received approval from the Food and Drug Administration for the generic version.
The generic, oxcarbazepine, is used for monotherapy or adjunctive therapy for the treatment of partial seizures in adults as well as monotherapy and adjunctive therapy in children aged 4 years and older with epilepsy.
Trileptal had sales of about $640 million for the year ended June 30, 2007, according to IMS data. The generic will be available in three strengths, 150 mg, 300 mg and 600 mg.
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.