| Inflammatory Conditions | Inflectra | Infliximab-dyyb | Biosimilar | 5-Apr-16 | Celltrion Inc |
| Inflammatory Conditions | Erelzi | Etanercept-szzs | Biosimilar | 30-Aug-16 | Sandoz |
| Inflammatory Conditions | Amjevita | Adalimumab-atto | Biosimilar | 23-Sep-16 | Amgen Inc |
| Vaginal Disorder | Intrarosa | Prasterone | New Active Ingredient | 16-Nov-16 | Endoceutics Inc |
| Health and Nutrition | Smoflipid 20% | Fish Oil, Medium Chain Triglycerides, Olive Oil, Soybean Oil | New Active Ingredient | 13-Jul-16 | Fresenius Kabi USA LLC |
| Diagnostic Agent | E-Z-HD | Barium Sulfate | New Active Ingredient | 11-Jan-16 | Bracco Diagnostics Inc |
| Diagnostic Agent | Varibar | Barium Sulfate | New Active Ingredient | 14-Oct-16 | Bracco Diagnostics Inc |
| Diagnostic Agent | Readi-Cat 2 | Barium Sulfate | New Active Ingredient | 15-Jan-16 | Bracco Diagnostics Inc |
| Blood Disorder | Provayblue | Methylene Blue | New Active Ingredient | 8-Apr-16 | Provepharm SAS |
| Heart Disease | Yosprala | Aspirin, Omeprazole | New Combination | 14-Sep-16 | Aralez Pharmaceuticals |
| COPD | Bevespi Aerosphere | Formoterol Fumarate, Glycopyrrolate | New Combination | 25-Apr-16 | Pearl Theraps Inc |
| Diabetes | Odefsey | Linagliptin, Metformin Hydrochloride | New Combination | 27-May-16 | Boehringer Ingelheim |
| Diabetes | Invokamet XR | Canagliflozin, Metformin Hydrochloride | New Combination | 20-Sep-16 | Janssen Pharms |
| Diabetes | Soliqua | Insulin Glargine, Lixisenatide | New Combination | 21-Nov-16 | Sanofi-Aventis US |
| Diabetes | Xultophy | Insulin Degludec, Liraglutide | New Combination | 21-Nov-16 | Novo Nordisk Inc |
| Heart Disease | Byvalson | Nebivolol Hydrochloride, Valsartan | New Combination | 3-Jun-16 | Forest Labs LLC |
| HIV | Odefsey | Emtricitabine, Rilpivirine Hydrochloride, Tenofovir Alafenamide Fumarate | New Combination | 1-Mar-16 | Gilead Sciences Inc |
| HIV | Descovy | Emtricitabine, Tenofovir Alafenamide Fumarate | New Combination | 4-Apr-16 | Gilead Sciences Inc |
| Antibacterial | Otovel | Ciprofloxacin Hydrochloride, Fluocinolone Acetonide | New Combination | 29-Apr-16 | Laboratorios Salvat SA |
| Gastrointestinal Disorder | Relistor | Methylnaltrexone Bromide | New Dosage Form | 19-Jul-16 | Salix Pharmaceuticals, Inc |
| Diabetes | Synjardy XR | Empagliflozin, Metformin Hydrochloride | New Dosage Form | 9-Dec-16 | Boehringer Ingelheim |
| Heart Disease | GoNitro | Nitroglycerin | New Dosage Form | 8-Jun-16 | Pohl Boskamp |
| Gastrointestinal Disorder | Dexilant SoluTab | Dexlansoprazole | New Dosage Form | 26-Jan-16 | Takeda Pharms USA |
| Hepatitis C | Viekira XR | Dasabuvir Sodium, Ombitasvir, Paritaprevir, Ritonavir | New Dosage Form | 22-Jul-16 | Abbvie |
| Heart Disease | Qbrelis | Lisinopril | New Dosage Form | 29-Jul-16 | Silvergate Pharms |
| HIV | Selzentry | Maraviroc | New Dosage Form | 4-Nov-16 | ViiV Healthcare |
| Inflammatory Conditions | Xeljanz XR | Tofacitinib Citrate | New Dosage Form | 23-Feb-16 | Pfizer Inc |
| Migraine | Onzetra Xsail | Sumatriptan Succinate | New Dosage Form | 27-Jan-16 | Avanir Pharms |
| Nausea, Vomiting | Syndros | Dronabinol | New Dosage Form | 1-Jul-16 | Insys Dev Co Inc |
| Nausea, Vomiting | Sustol | Granisetron | New Dosage Form | 9-Aug-16 | Heron Theraps Inc |
| Oncology | Cabometyx | Cabozantinib S-Malate | New Dosage Form | 25-Apr-16 | Exelixis Inc |
| Opioid Dependence | Probuphine | Buprenorphine Hydrochloride | New Dosage Form | 26-May-16 | Braeburn Pharms Inc |
| Mental/Neurological Disorder | Carnexiv | Carbamazepine | New Dosage Form | 7-Oct-16 | Lundbeck LLC |
| Skin Disorder | Sernivo | Betamethasone Dipropionate | New Dosage Form | 5-Feb-16 | Promius Pharma LLC |
| Mental/Neurological Disorder | Adzenys XR-ODT | Amphetamine | New Dosage Form | 27-Jan-16 | Neos Therapeutics, Inc |
| Heart Disease | Akovaz | Ephedrine Sulfate | New Dosage Form | 29-Apr-16 | Flamel Ireland Ltd |
| Migraine | Zembrace SymTouch | Sumatriptan Succinate | New Dosage Form | 28-Jan-16 | Dr Reddys Labs Ltd |
| Oncology | Evomela | Melphalan Hydrochloride | New Dosage Form | 10-Mar-16 | Spectrum Pharms |
| Vitamins and Minerals | Rayaldee | Calcifediol | New Dosage Form | 17-Jun-16 | Opko Ireland Global Holdings Ltd. |
| Weight Loss | Belviq XR | Lorcaserin Hydrochloride | New Dosage Form | 15-Jul-16 | Eisai Inc |
| Blood Disorder | Triferic | Ferric Pyrophosphate Citrate | New Dosage Form | 25-Apr-16 | Rockwell Medical Inc |
| Skin Disorder | Ameluz | Aminolevulinic Acid Hydrochloride | New Dosage Form | 10-May-16 | Biofrontera Bioscience Gmbh |
| Ophthalmic Conditions | Photrexa | Riboflavin 5'-Phosphate Sodium | New Dosage Form | 15-Apr-16 | Avedro Inc |
| Heart Disease | Esmolol Hydrochloride In Plastic Container | Esmolol Hydrochloride | New Dosage Form | 7-Apr-16 | HQ Specialty Pharma Corp |
| Diagnostic Agent | Ruby-Fill | Rubidium Chloride Rb-82 | New Dosage Form | 30-Sep-16 | Jubilant Draximage Inc |
| Mental/Neurological Disorder | Fycompa | Perampanel | New Dosage Form | 29-Apr-16 | Eisai Inc |
| Hepatic Disorder | Cetylev | Acetylcysteine | New Dosage Form | 29-Jan-16 | Arbor Pharmaceuticals LLC |
| Orphan Disease | Orfadin | Nitisinone | New Dosage Form | 22-Apr-16 | Swedish Orphan Biovitrum Ab Publ |
| Opioid Pain Management | Troxyca ER | Oxycodone, Naltrexone | New Dosage Form, New Combination | 1-Aug-19 | Pfizer Inc |
| Anesthesia | Kovanaze | Oxymetazoline Hydrochloride, Tetracaine Hydrochloride | New Dosage Form, New Combination | 29-Jun-16 | St Renatus LLC |
| Hemophilia | Idelvion | Coagulation Factor IX (Recombinant), Albumin Fusion Protein | New Formulation | 4-Mar-16 | CSL Behring |
| Hemophilia | Kovaltry | Antihemophilic Factor [Recombinant] | New Formulation | 16-Mar-16 | Bayer Healthcare, LLC |
| Hemophilia | Afstyla | Antihemophilic Factor [Recombinant], Single Chain | New Formulation | 25-May-16 | CSL Behring, LLC |
| Immune Deficiency | Cuvitru | [Immune Globulin Subcutaneous (Human)] 20% | New Formulation | 13-Sep-16 | Baxalta US, Inc. |
| Contraceptives | Kyleena | Levonorgestrel-Releasing Intrauterine System | New Strength | 16-Sep-16 | Bayer Healthcare |
| Nausea, Vomiting | Bonjesta | Doxylamine Succinate, Pyridoxine Hydrochloride | New Strength | 7-Nov-16 | Duchesnay |
| Ophthalmic Conditions | BromSite | Bromfenac Sodium | New Strength | 8-Apr-16 | Sun Pharma Global |
| Opioid Pain Management | Xtampza ER | Oxycodone | New Strength | 26-Apr-16 | Collegium Pharm Inc |
| Hepatitis B | Vemlidy | Tenofovir Alafenamide Fumarate | New Strength | 10-Nov-16 | Gilead Sciences Inc |
| Skin Disorder | Aczone | Dapsone | New Strength | 24-Feb-16 | Allergan Inc |
| Opioid Dependence | Evzio | Naloxone Hydrochloride | New Strength | 19-Oct-16 | Kaleo Inc |
| Infectious Diseases | Vermox | Mebendazole | New Strength | 19-Oct-16 | Janssen Pharmaceuticals Inc |
| Vaccinations | Vaxchora | Cholera Vaccine | New Vaccine | 10-Jun-16 | Pax Vax Bermuda Ltd. |
| Vaccinations | Flucelvax Quadrivalent | Influenza Vaccine | New Vaccine Formulation | 24-May-16 | Seqirus, Inc. |
| Vaccinations | Afluria Quadrivalent | Influenza Vaccine | New Vaccine Formulation | 29-Aug-16 | Seqirus Pty. Ltd. |
| Vaccinations | Flublok Quadrivalent | Influenza Vaccine | New Vaccine Formulation | 11-Oct-16 | Protein Sciences Corporation |
| Orphan Disease | Defitelio | Defibrotide Sodium | Novel Drug | 30-Mar-16 | Jazz Pharmaceuticals, Inc |
| Asthma | Cinqair | Reslizumab | Novel Drug | 23-Mar-16 | Teva Pharmaceuticals |
| Diabetes | Adlyxin | Lixisenatide | Novel Drug | 27-Jul-16 | Sanofi-Aventis U.S. LLC |
| Orphan Disease | Ocaliva | Obeticholic Acid | Novel Drug | 27-May-16 | Intercept Pharmaceuticals |
| Hepatitis C | Zepatier | Elbasvir, Grazoprevir | Novel Drug | 28-Jan-16 | Merck & Co. |
| Hepatitis C | Epclusa | Sofosbuvir, Velpatasvir | Novel Drug | 28-Jun-16 | Gilead Sciences Inc |
| Mental/Neurological Disorder | Nuplazid | Pimavanserin | Novel Drug | 29-Apr-16 | Acadia Pharms Inc |
| Orphan Disease | Exondys 51 | Eteplirsen | Novel Drug | 19-Sep-16 | Sarepta Theraps Inc |
| Multiple Sclerosis | Zinbryta | Daclizumab | Novel Drug | 27-May-16 | Biogen, Inc. |
| Orphan Disease | Spinraza | Nusinersen | Novel Drug | 23-Dec-16 | Biogen Idec |
| Oncology | Venclexta | Venetoclax | Novel Drug | 11-Apr-16 | Abbvie Inc |
| Oncology | Tecentriq | Atezolizumab | Novel Drug | 18-May-16 | Genentech Inc |
| Orphan Oncology Disease | Lartruvo | Olaratumab | Novel Drug | 19-Oct-16 | Eli Lilly And Co |
| Orphan Oncology Disease | Rubraca | Rucaparib | Novel Drug | 19-Dec-16 | Clovis Oncology Inc |
| Ophthalmic Conditions | Xiidra | Lifitegrast Ophthalmic Solution | Novel Drug | 11-Jul-16 | Shire Dev Llc |
| Infectious Diseases | Zinplava | Bezlotoxumab | Novel Drug | 21-Oct-16 | Merck Sharp Dohme |
| Mental/Neurological Disorder | Briviact | Brivaracetam | Novel Drug | 18-Feb-16 | UCB Inc |
| Skin Disorder | Taltz | Ixekizumab | Novel Drug | 22-Mar-16 | Eli Lilly And Co |
| Skin Disorder | Eucrisa | Crisaborole | Novel Drug | 14-Dec-16 | Anacor Pharms Inc |
| Orphan Disease | Anthim | Obiltoxaximab | Novel Drug | 18-Mar-16 | Elusys Therapeutics Inc |
| Diagnostic Agent | Axumin | Fluciclovine F-18 | Novel Drug | 27-May-16 | Blue Earth |
| Diagnostic Agent [Orphan] | Netspot | Gallium Dotatate Ga-68 | Novel Drug | 1-Jun-16 | AAA USA Inc |
