Precedex, dexmedetomidine hydrochloride, is approved to sedate patients with breathing tubes in an intensive-care setting, as well as patients without breathing tubes before and during surgeries and other procedures. Hospira’s patent that covers the use of Precedex in an intensive-care setting in due to expire in 2019, however other patents have already expired. On Monday, the FDA approved the sale of generic copies of the drug as long as the companies leave out information from the prescribing labels about uses that are covered under Hospira’s patent, including “intensive-care unit sedation.”
FDA has approved apixaban (Eliquis, Bristol-Myers Squibb and Pfizer) for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE.
FDA has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.
FDA has approved peginterferon beta-1a (Plegridy, Biogen Idec) for the treatment of adults with relapsing forms of multiple sclerosis (MS).
FDA has approved eliglustat (Cerdelga, Genzyme), the only first-line oral therapy for the long-term treatment of adults with the Type 1 form of Gaucher disease.