Mylan affirms clozapine bioequivalence
Mylan markets the generic clozapine product through its Bertek Pharmaceuticals division. Bertek reports that with more than 22,000 prescriptions for it's clozapine brand, only 20 adverse events have been received by it's Drug Safety Surveillance Group. To assure physicians, pharmacists, and other healthcare professionals of the bioequivalence of it's product, the division is sending letters to ensure they have the information they need to treat the appropriate patients with Bertek's product and to utilize the company's confidential, online patient registry system.
According to vice president of clinical research James H. Sherry, a former medical reviewer at the Neuropharmacology Division of the FDA, the generic clozapine product was tested according to established FDA requirements and was found by the FDA to be bioequivalent and, therefore, therapeutically equivalent to the Novartis brand.
"Although retail pharmacy prices vary, Mylan prices its clozapine significantly less than the Novartis brand to help patients and their families, who are living with this critically disabling condition, save on their prescription drug costs," Sherry added.
Mylan Laboratories has been developing and manufacturing generic pharmaceuticals in the United States since 1972. Last year, Mylan produced over 9 billion dosage units of medicine.
For more information, contact Patricia Sunseri of Mylan Laboratories at 412-232-0100.
Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online