ICYMI: FDA’s biggest announcements from 2013

January 30, 2014

January – lowers recommended dose for certain sleep drugs containing zolpidem (e.g. Ambien, Zolpimist); approves 3 new drug txs for type 2 diabetes (Nesina, Kazano, Oseni); approves new orphan drug Kynamro to treat inherited cholesterol disorder

February – approves first retinal implant for adults with rare genetic eye disease; approves new treatment Kadcyla for late-stage breast cancer

March – approves Invokana to treat type 2 diabetes, Tecfidera new tx for MS; TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients

April – approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older; approves Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults; approves Diclegis for pregnant women experiencing nausea and vomiting

May – approves Simponi to treat ulcerative colitis; approves new drug for advanced prostate cancer

June – approves the first non-hormonal treatment for hot flashes associated with menopause; approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential

July – announces a voluntary recall of Nova Max Blood Glucose Test Strips; approves new treatment for a type of late-stage lung cancer

August – approves Tivicay (dolutegravir); a new drug to treat HIV-1 infection and the first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies

September – approves Brintellix for Major depressive disorder and Abraxane for late-stage pancreatic cancer

October – approves Opsumit for pulmonary arterial hypertension and Adempas for pulmonary hypertension; hydrocodone product Zohydro ER

November – removes restrictions on prescribing diabetes drug Avandia; approves a medical device to treat epilepsy; new treatment Olysio for hep C virus and an adjudicated vaccine for bird flu H5N1

December – approves generic versions of Cymbalta; approves Sovaldi for chronic hep C; first treatment for Peyronie’s disease; addresses antibacterial soaps