The drug's key patents expired in March. Sales reached about $2.4 billion in 2008.
Teva says it has started shipping generic versions of the drug.
FDA approval for product to prevent cardiac adhesions
A material developed at the Hebrew University of Jerusalem that is designed to prevent adhesions (scar tissue) following surgery has led to approval by the U.S. Food and Drug Administration (FDA) of a product for use in pediatric cardiac surgery patients.
The product is the result of Prof. Daniel Cohn's invention of novel, tailor-made, biodegradable polymers for the prevention of post-surgical adhesions. SyntheMed Inc. of Iselin, N.J. in the U.S., received the technology from Yissum the Technology Transfer Company of the Hebrew University, and has now obtained FDA pre-market approval for the first product, REPEL-CVš Adhesion Barrier, for use in pediatric patients (21 and younger) who are likely to need secondary open heart surgery.
The generation of adhesions following heart surgery is of special concern, since they may affect cardiac function. Furthermore, in the frequent cases where repeat operations are required, adhesions obscure cardiac landmarks, making the procedure potentially life-threatening to the patient due to inadvertent vascular or cardiac injury.
In the U.S., there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected, while other children require additional operations as they grow. The REPEL-CVš Adhesion Barrier product gives physicians another tool to help decrease the complications that may occur during these surgeries. .
"I am very excited that the long process that started several years ago in our laboratory at the Institute of Chemistry of the Hebrew University with the design and synthesis of a family of biodegradable polymers was recently approved by the FDA," said Prof. Cohn.
"This biomedical product harnessed the unique properties of a family of custom-made, biodegradable polymers aimed at treating a large, incredibly widespread clinical problem, which pertains to all surgeries: post-operative adhesions. Each and every surgery conducted inevitably results in post-surgical adhesions, and the polymeric film developed at the Hebrew University allows us to minimize those adhesions."
The approval by the FDA came after its approval in Europe and Canada. Receiving the approval of the different regulatory agencies was the result of the work of a large team. It started with the research conducted by Prof. Cohn and his students, who largely contributed to this endeavor, and continued with the work done at SyntheMed Inc., that developed the product and brought it to the clinic.
"I would like to thank each and all of them and acknowledge their pivotal contribution to the success of this project, all along the journey," said Prof. Cohn.
Teva Pharmaceutical Industries Ltd. said Friday it received Food and Drug Administration approval for a generic version of Johnson & Johnson's epilepsy drug Topamax.