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ARTICLE

An Overview of Infectious Disease Medications Approved in 2016 and Outlook Through 2017

JAN 01, 2017 | MICHAEL R. PAGE, PHARMD, RPH
Table 1: New Medications Approved in 2016
 
PRODUCT INDICATION COMPANY APPROVAL DATE
Zepatier (elbasvir/ grazoprevir) Indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infection in adults Merck Sharpe & Dohme 01/28/2016
Aczone (dapsone 7.5% gel) Indicated for the topical treatment of acne vulgaris in patients 12 years and older Allergan 02/24/2016
Odefsey (emtricitabine/rilpivirine HCl/tenofovir alafenamide fumarate)
 
Indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years and older as initial therapy in those with no antiretroviral
treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL, or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with
no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey
Gilead 03/01/2016
Anthim (obiltoxaximab) Indicated in adult and pediatric patients for treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate Elusys Therapeutics 03/18/2016
Descovy (emtricitabine/tenofovir alafenamide fumarate) Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older          Gilead 04/04/2016
Acticlate (doxycycline hyclate) Indicated for treatment of rickettsial infections; sexually transmitted infections; respiratory tract infections; specific bacterial infections; ophthalmic infections; anthrax, including inhalational anthrax (postexposure); alternative treatment for selected infections when penicillin is contraindicated; adjunctive therapy for acute intestinal amebiasis and severe acne; prophylaxis of malaria Aqua 04/26/2016
Otovel (ciprofloxacin HCl/fluocinolone
acetonide)
Indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella
catarrhalis, and Pseudomonas aeruginosa
Arbor 04/29/2016
Epclusa (sofosbuvir/ velpatasvir) Indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection Gilead 06/28/2016
Viekira XR (dasabuvir sodium/ ombitasvir/ parita- previr/ritonavir) Indicated for the treatment of adult patients with chronic hepatitis C virus, including genotype 1b infection without cirrhosis or with compensated cirrhosis, and genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin AbbVie 07/22/2016
Vaxchora (cholera vaccine, live oral) Indicated for active immunization against disease caused by Vibrio cholerae serogroup O1; approved for use in adults 18 through 64 years of age traveling to cholera-affected areas PaxVax 10/03/2016
Zinplava (bezlotoxumab) Indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence Merck Sharp & Dohme 10/21/2016
Selzentry (maraviroc)— new indication Indicated for pediatric use in patients 2 years or older weighing at least 10 kilograms ViiV Healthcare 11/04/2016
Vemlidy (tenofovir alafenamide) Indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease Gilead 11/10/2016
 

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