Erin Bastick
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.
Eli Lilly's Cyramza approved for lung cancer
FDA has approved Cyramza (ramucirumab, Eli Lilly) in combination with docetaxel to treat aggressive non-small cell lung cancer.
FDA panel recommends Actavis' antibiotic for approval
Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.
Blincyto to treat lymphoblastic leukemia approved, carries boxed warning
FDA has approved blinatumomab (Blincyto, Amgen) immunotherapy for the treatment of relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia.
New antiarrhythmic agent gets FDA approval
FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharamceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.
FDA: Keep boxed warning on Chantix
An FDA advisory committee has voted to keep the boxed warning for varenicline (Chantix, Pfizer) that states that the drug may cause serious neuropsychiatric events.
FDA approves abuse-deterrent labeling for Embeda
FDA has approved an updated labeling of morphine sulfate/naltrexone hydrochloride (Embeda, Pfizer) extended release capsules, CII, to include abuse-deterrent properties
FDA approves antiemetic agent for prevention of chemotherapy-induced nausea and vomiting
FDA has approved netupitant/palonosetron (Akynzeo, Eisai Inc.) to treat chemotherapy-induced nausea and vomiting (CINV).
FDA fast tracks ALS drug
FDA has designated new ALS stem cell therapy from BrainStorm Cell Therapeutics as a “fast-track” product.
Hospira scores temporary win in lawsuit versus FDA
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 approves Arnuity Ellipta for asthma
FDA has approved fluticasone furoate inhalation powder (Arnuity Ellipta, GlaxoSmithKline) for maintenance treatment of asthma in patients aged 12 years and older.