Liquid Pamidronate Disodium Injection Approved

June 1, 2002

Bedford Laboratories announced that it has received approval from the Food and Drug Administration to market pamidronate disodium for injection. The product will be the only liquid version available on the market, and is equivalent to the Novartis pamidronate disodium product (Aredia), a bone resorption inhibitor indicated for the treatment of hypercalcemia associated with malignancy, for Paget’s disease, and for osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

Bedford Laboratories announced that ithas received approval from the Food and Drug Administration to marketpamidronate disodium for injection. The product will be the only liquid versionavailable on the market, and is equivalent to the Novartis pamidronate disodiumproduct (Aredia), a bone resorption inhibitor indicated for the treatment ofhypercalcemia associated with malignancy, for Paget’s disease, and forosteolytic bone metastases of breast cancer and osteolytic lesions of multiplemyeloma.

"We expect hospitals to appreciate the added convenienceof our presentation, which is a solution, compared to Aredia, which requiresreconstitution," said Tom Murphy, a general manager at BedfordLaboratories. "Although a solution, it is entirely equivalent in functionto Aredia—just easier to use."

Pamidronate disodium injection will be supplied in twopresentations, a 30 mg/10 mL vial and a 90 mg/10 mL vial.