Novartis receives FDA approval for COPD drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.
The FDA approved Arcapta Neohaler (indacaterol inhalation powder) for long-term, once-daily maintenance of bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema.
COPD, which often results from cigarette smoking, is the fourth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention.
Arcapta Neohaler is marketed by Novartis Pharmaceuticals Corp., an East Hanover, N.J.-based subsidiary of the Swiss drug maker.
Lazanda approved as breakthrough pain treatment
BEDMINSTER, N.J. — The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.
Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating and occurs despite otherwise appropriate pain therapy.
“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” Archimedes Pharma CEO Jeffrey Buchalter said. “Lazanda, which uses our patented PecSys drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”
APP Pharmaceuticals gets FDA OK for myxedema coma treatment
SCHAUMBURG, Ill. — APP Pharmaceuticals has received regulatory approval for the treatment of a complication related to hypothyroidism.
APP said that its levothyroxine sodium for injection will be marketed in single-dose 100-mcg, 200-mcg and 500-mcg vials. The drug is designed to treat myxedema coma, a life-threatening complication of hypothyroidism.
“APP worked closely with the FDA to secure approval of levothyroxine sodium for injection because of the expressed medical need for this drug,” APP Pharmaceuticals president and CEO John Ducker said. “We will continue to collaborate with the FDA to gain approval of established and much-needed drugs that maintain the highest standards of quality, safety and efficacy.”