Cimzia gets FDA nod for Crohn’s Disease
The FDA has approved UCB Corp’s Cimzia® (certolizumab pegol) for the treatment of Crohn’s Disease (CD). The company aims to make the drug, which is a new, promising option for patients suffering from moderate to severe Crohn’s Disease, available in the U.S. in the next few days. Cimzia is the first and only pegylated anti-TNF? (anti-tumor necrosis factor-?). The excessive production of TNF? has been associated with a wide variety of diseases.


Israel-based
The FDA has delayed the final approval of
DA approval for its NDA (New Drug Application) for Flo-Pred (prednisolone acetate oral suspension) in its NonSpil liquid drug delivery system. Flo-Pred is an anti-inflammatory agent used in the treatment of asthma, certain allergic and dermatologic conditions as well as various other indications. Taro expects to launch the product later this year. Adverse reactions common to corticosteroids include fluid retention, high blood pressure, high blood sugar, mood swings and weight gain.
bmitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.