FDA approves ANDA for Akorn-Strides’ Pamidronate Disodium Injection
The U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application for Akorn-Strides‘ Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. The joint venture between Akorn and Strides was formed to develop liquid, dry powder and lyophilized formulations of generic injectable pharmaceuticals for a wide market with focus on painkillers, anti-infectives and CNS medications. Pamidronate Disodium Injection has received the indication for use in the treatment of hypercalcemia related to tumors and Paget’s disease.
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