Table 7

Selected Drugs and Biologics That Have Received or May Receive FDA-Approved Labeling in 2017a

Drug or BiologicManufacturer(s)IndicationRouteQuarter and Year of PDUFA Dateb
Telotristat etiprateLexicon PharmaceuticalsCarcinoid syndromeOralQ1 2017
DupilumabRegeneron PharmaceuticalsModerate-to-severe atopic dermatitisSubcutaneousQ1 2017
OcrelizumabGenentechRelapsing and primary progressive multiple sclerosisI.V.Q1 2017
AbaloparatideRadius HealthPostmenopausal osteoporosisSubcutaneousQ1 2017
ValbenazineNeurocrine BiosciencesTardive dyskinesiaOralQ2 2017
BaricitinibEli Lilly and CompanyModerate-to-severe rheumatoid arthritisOralQ2 2017
Cerliponase alfaBioMarin PharmaceuticalClassic late infantile neuronal ceroid lipofuscinosisIntracerebralQ2 2017
BrigatinibARIAD PharmaceuticalsNon-small-cell lung cancerOralQ2 2017
RibociclibNovartisAdvanced breast cancerOralQ2 2017
17β-estradiolTherapeuticsMDDyspareunia in postmenopausal women with vulvar and vaginal atrophyVaginallyQ2 2017
MidostaurinNovartisAdult acute myeloid leukemiaOralQ2 2017
Nonacog beta pegol (long-acting factor IX)Novo NordiskHemophilia BI.V.Q2 2017
AvelumabEMD Serono and PfizerMerkel cell carcinomaI.V.Q2 2017
DurvalumabAstraZenecaUrothelial carcinomaI.V.Q2 2017
EdaravoneMitsubishi Tanabe Pharma CorporationAmyotrophic lateral sclerosisI.V.Q2 2017
Methylphenidate extended-release orally disintegrating tabletNeos TherapeuticsAttention-deficit/hyperactivity disorderOralQ2 2017
BinimetinibArray BioPharmaMelanomaOralQ2 2017
NiraparibTESAROEpithelial ovarian, fallopian tube, or primary peritoneal cancerOralQ2 2017
RomosozumabAmgen and UCBOsteoporosisSubcutaneousQ3 2017
NeratinibPuma BiotechnologyExtended adjuvant treatment (posttrastuzumab) in early-stage breast cancerOralQ3 2017
BelimumabGlaxoSmithKlineAutoantibody-positive systemic lupus erythematosusSubcutaneousQ3 2017
Glecaprevir–pibrentasvirEnanta PharmaceuticalsChronic hepatitis C virus, all major genotypesOralQ3 2017
Voxilaprevir–velpatasvir–sofosbuvirGilead SciencesDirect-acting antiviral-experienced chronic hepatitis C virusOralQ3 2017
Amantadine extended releaseAdamas PharmaceuticalsLevodopa-induced dyskinesia in patients with Parkinson’s diseaseOralQ3 2017
Human antirabies immunoglobulinKedrion Biopharma and Kamada Ltd.Postexposure treatment of rabiesIntramuscularQ3 2017
Amphetamine extended-release liquid suspensionNeos TherapeuticsAttention-deficit/hyperactivity disorderOralQ3 2017
Fluticasone furoate–umeclidinium–vilanterolGlaxoSmithKlineChronic obstructive pulmonary diseaseInhaledQ3 2017
SirukumabJanssen BiotechModerately to severely active rheumatoid arthritisSubcutaneousQ3 2017
FX006Flexion TherapeuticsOsteoarthritis of the kneeIntraarticularQ4 2017
Nonlive, recombinant herpes zoster vaccineGlaxoSmithKlinePrevention of herpes zosterIntramuscularQ4 2017
GuselkumabJanssen BiotechModerate-to-severe plaque psoriasisSubcutaneousQ4 2017
SemaglutideNovo NordiskType 2 diabetes in adultsSubcutaneousQ4 2017
  • a FDA = Food and Drug Administration, PDUFA = Prescription Drug User Fee Act, Q = quarter.

  • b Extrapolated based on new drug application submission date and review status (i.e., 10 months for standard review and 6 months for priority review).