The FDA has approved Incruse Ellipta (umeclidinium inhalation powder), an anticholinergic, for longterm, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Incruse Ellipta is for oral inhalation only. The inhaler contains a double-foil blister strip of powder formulation. For maintenance treatment of COPD, 1 inhalation of Incruse Ellipta once daily is recommended.
Inhalation powder: umeclidinium 62.5 mcg per blister
For More Information
Antares Pharma, Inc
The FDA has approved Otrexup (methotrexate) injection to treat rheumatoid arthritis (RA) and psoriasis in adults, and polyarticular idiopathic arthritis (pJIA) in children. Otrexup is for once-weekly subcutaneous use only and should be administered in the abdomen or thigh. The starting doses are as follows: for RA, 7.5 mg once weekly; for pJIA, 10 mg/ m2 once weekly; for psoriasis, 10 to 25 mg once weekly of an oral, intramuscular, subcutaneous, or intravenous formulation.
Single-dose autoinjector: 10, 15, 20, or 25 mg
For More Information: www.otrexup.com
The FDA has approved Xartemis XR (oxycodone hydrochloride and acetaminophen) Extended- Release Tablets for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. The recommended dose of Xartemis XR is 2 tablets every 12 hours without regard to food. Tablets should be swallowed whole, and complete swallowing should be ensured immediately after placing them in the mouth.
Extended-release tablets (oxycodone hydrochloride/acetaminophen): 7.5 mg/325 mg
For More Information: www.xartemisxr.com
Merck & Co, Inc
The FDA has approved Ragwitek (short ragweed pollen allergen extract) as immunotherapy for the treatment of short ragweed pollen– induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Ragwitek is approved for use in adults 18 through 65 years of age. The recommended dosage is 1 tablet daily sublingually.
Tablets: 12 Amb a 1-unit
For More Information: www.ragwitek.com