APP Gets FDA Approval for Dexamethasone Sodium Phosphate

American Pharmaceutical Partners (APP) has received approval from the FDA for the abbreviated new drug application (ANDA) of Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL, (preserved).

APP's product is bioequivalent to the listed drug, Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL of Sicor Pharmaceuticals. Dexamethasone Sodium Phosphate Injection, a synthetic adrenocortical steroid anti-inflammatory drug, is used by intravenous or intramuscular injection when oral therapy is not feasible and indicated for endocrine, rheumatic and hematologic disorders; collagen, dermatologic, ophthalmic, gastrointestinal, respiratory and neoplastic diseases; allergic and edematous states; and cerebral edema.