SCHAUMBURH, Ill. (June 1, 2004) – American Pharmaceutical Partners (AAP) announced it has received approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Terbutaline Sulfate Injection, USP.
Terbutaline is indicated for the prevention and reversal of bronchospasm in patients over the age of 12 with bronchial asthma and reversible bronchospasm associated with bronchitis and emphysema. The drug is the generic equivalent of aaiPharma Inc.’s Brethine Injection, according to AAP.
“Terbutaline … brings to four the number of ANDA approvals AAP has received thus far in 2004,” said Dr. Patrick Soon-Shiong, chairman, president and chief executive officer of American Pharmaceutical Partners.
AAP will offer its terbutaline product in vials as opposed to glass ampules.
