SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said. The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients ages 6 years and older. The drug maker plans to launch the drug in early 2013. Asthma affects more than 24 million Americans, according to the Centers for Disease Control and Prevention, and healthcare market research firm IMS Health estimated the market for inhaled steroids to be worth $8.3 billion.
Drug maker Vivus has released what it called the first new drug in 13 years for chronic weight management in adults. The company announced the availability of Qsymia (phentermine and topiramate) extended-release capsules, which it is formally introducing to medical professionals at the Obesity Society’s annual scientific meeting in San Antonio. The drug, which is classified as a schedule IV controlled substance by the Drug Enforcement Administration, has a risk evaluation and mitigation strategy, or REMS. In addition to a medication guide, healthcare provider training, patient brochure and other educational materials, the drug is only available through certified mail-order pharmacies that are part of the Qsymia Home Delivery Network, including CVS Pharmacy and Walgreens.
A subsidiary of Johnson & Johnson is hoping to gain FDA approval for a new formulation of one of its drugs. Janssen Biotech announced that it had filed an application with the FDA seeking approval for an intravenous formulation of Simponi (golimumab) in adults with moderately to severely active rheumatoid arthritis, which affects an estimated 1.5 million Americans. The FDA approved the subcutaneously injected formulation of Simponi in April 2009 for moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.