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.
“With this approval, APP now has the broadest portfolio of dexamethasone sodium phosphate products in the industry enabling the company to fully participate in this market,” said Al Heller, president and CEO of the company. “This is the second abbreviated new drug application (ANDA) approval APP has received thus far in 2005.”
The company said that it expects to commence marketing dexamethasone sodium phosphate injection USP, 10mg/mL shortly.
American Pharmaceutical Partners is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.