FDA Approves two ANDAs for for Dexamethasone Sodium Phosphate Injection
The U.S. Food and Drug Administration has announced the approval of Akorn-Strides’ two ANDAs for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL in 1mL, 5 mL, and 30 mL vials, and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL in 10 mL vials. Akorn-Strides, LLC, a Joint Venture that was formed in 2005 by Akorn, Inc. and Strides Arcolab Limited aims to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting a number of ditherapeutic markets with a major focus on anti-infectives, analgesics and CNS drugs. The injection is used in the treatment of endocrine disorders, arthritis, blood disorders, dermatologic diseases, severe allergic reactions, eye diseases, certain cancers, gastrointestinal diseases and respiratory diseases.
