Novel Drug Approvals for 2018
2018 New Approvals Report (PDF - 2 MB)
Text Version
Helping Guide the Way for New Medicines
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. With its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat, CDER provides scientific and regulatory advice needed to bring new therapies to market.
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.
A Wide Range of Products
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products approved by CDER and organized by calendar year. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved by the Center for Biologics Evaluation and Research.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.
New Molecular Entities (NMEs)
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act.
| No. | Drug Name |
Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 59. | Ultomiris | ravulizumab | 12/21/2018 | To treat paroxysmal nocturnal hemoglobinuria (PNH) Press Release Drug Trials Snapshot |
| 58. | Elzonris | tagraxofusp-erzs | 12/21/2018 | To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) Press Release Drug Trials Snapshot |
| 57. | Asparlas | calaspargase pegol-mknl | 12/20/2018 | To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years Drug Trials Snapshot |
| 56. | Motegrity | prucalopride | 12/14/2018 | To treat chronic idiopathic constipation Drug Trials Snapshot |
| 55. | Xospata | gilteritinib | 11/28/2018 | To treat patients who have relapsed or refractory acute myeloid leukemia (AML) Press Release Drug Trials Snapshot |
| 54. | Firdapse | amifampridine | 11/28/2028 | To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults Press Release Drug Trials Snapshot |
| 53. | Vitrakvi | larotrectinib | 11/26/2018 | To treat patients whose cancers have a specific genetic feature (biomarker) Press Release Drug Trials Snapshot |
| 52. | Daurismo | glasdegib | 11/21/2018 | To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients Press Release Drug Trials Snapshot |
| 51. | Gamifant | emapalumab-lzsgemapalumab-lzsg | 11/20/2018 | To treat primary hemophagocytic lymphohistiocytosis (HLH) Press Release Drug Trials Snapshot |
| 50. | Aemcolo | rifamycin | 11/16/2018 | To treat travelers’ diarrhea Press Release Drug Trials Snapshot |
| 49. | Yupelri | revefenacin | 11/9/2018 | To treat patients with chronic obstructive pulmonary disease (COPD) Drug Trials Snapshot |
| 48. | Lorbrena | lorlatinib | 11/2/2018 | To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer Drug Trials Snapshot |
| 47. | Xofluza | baloxavir marboxil | 10/24/2018 | To treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. Press Release Drug Trials Snapshot |
| 46. | Talzenna | talazoparib | 10/16/2018 | To treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation. Drug Trials Snapshot |
| 45. | Tegsedi | inotersen | 10/5/2018 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults Drug Trials Snapshot |
| 44. | Revcovi | elapegademase-lvlr | 10/5/2018 | To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) Drug Trials Snapshot |
| 43. | Nuzyra | omadacycline | 10/2/2018 | To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections Drug Trials Snapshot for community-acquired bacterial pneumonia |
| 42. | Seysara | sarecycline | 10/1/2018 | To treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older Drug Trials Snapshot |
| 41. | Libtayo | cemiplimab-rwlc | 9/28/2018 | To treat cutaneous squamous cell carcinoma (CSCC) Drug Trial Snapshot |
| 40. | Vizimpro | dacomitinib | 9/27/2018 | To treat metastatic non-small-cell lung cancer Drug Trials Snapshot |
| 39. | Emgality | galcanezumab-gnlm | 9/27/2018 | For the preventive treatment of migraine in adults Drug Trials Snapshot |
| 38. | Copiktra | duvelisib | 9/24/2018 | To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma Drug Trials Snapshot |
| 37. | Ajovy | fremanezumab-vfrm | 9/14/2018 | For the preventive treatment of migraine in adults Drug Trials Snapshot |
| 36. | Lumoxiti | moxetumomab pasudotox-tdfk | 9/13/2018 | To treat hairy cell leukemia Press Release Drug Trials Snapshot |
| 35. | Pifeltro | doravirine | 8/30/2018 | To treat HIV-1 infection in adult patients Drug Trials Snapshot |
| 34. | Xerava | eravacycline | 8/27/2018 | To treat complicated intra-abdominal infections in patients 18 years of age and older Drug Trials Snapshot |
| 33. | Takhzyro | lanadelumab | 8/23/2018 | To treat types I and II hereditary angioedema Drug Trials Snapshot |
| 32. | Oxervate | cenegermin-bkbj | 8/22/2018 | To treat neurotrophic keratitis Press Release Drug Trials Snapshot |
| 31. | Diacomit | stiripentol | 8/20/2018 | To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam Drug Trials Snapshot |
| 30. | Galafold | migalastat | 8/10/2018 | To treat treat adults with Fabry disease. Press Release Drug Trials Snapshot |
| 29. | Annovera | segesterone acetate and ethinyl estradiol vaginal system | 8/10/2018 | New vaginal ring used to prevent pregnancy for an entire year Press Release Drug Trials Snapshot |
| 28. | Onpattro | patisiran | 8/10/2018 | To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients Press Release Drug Trials Snapshot |
| 27. | Poteligeo | mogamulizumab-kpkc | 8/8/2018 | To treat two rare types of non-Hodgkin lymphoma Press Release Drug Trials Snapshot |
| 26. | Mulpleta | lusutrombopag | 7/31/2018 | To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure Drug Trials Snapshot |
| 25. | Omegaven | fish oil triglycerides | 7/27/2018 | As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis Drug Trials Snapshot |
| 24. | Orilissa | elagolix sodium | 7/23/2018 | For the management of moderate to severe pain associated with endometriosis Drug Trials Snapshot |
| 23. | Krintafel | tafenoquine | 7/20/2018 | For the radical cure (prevention of relapse) of Plasmodium vivax malaria Drug Trials Snapshot |
| 22. | Tibsovo | ivosidenib | 7/20/2018 | To treat patients with relapsed or refractory acute myeloid leukemia Press Release Drug Trials Snapshot |
| 21. | TPOXX | tecovirimat | 7/13/2018 | To treat smallpox Press Release Drug Trials Snapshot |
| 20. | Braftovi | encorafenib | 6/27/2018 | To treat unresectable or metastatic melanoma Drug Trials Snapshot |
| 19. | Mektovi | binimetinib | 6/27/2018 | To treat unresectable or metastatic melanoma Drug Trials Snapshot |
| 18. | Zemdri | plazomicin | 6/25/2018 | To treat adults with complicated urinary tract infections Drug Trials Snapshot |
| 17. | Epidioloex | cannabidiol | 6/25/2018 | To treat rare, severe forms of epilepsy Press Release Drug Trials Snapshot |
| 16. | Moxidectin | moxidectin | 6/13/2018 | To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older Drug Trials Snapshot |
| 15. | Olumiant | baricitinib | 5/31/2018 | To treat moderately to severely active rheumatoid arthritis Drug Trials Snapshot |
| 14. | Palynziq | pegvaliase-pqpz | 5/24/2018 | To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU) Press Release Drug Trials Snapshot |
| 13. | Doptelet | avatrombopag | 5/21/2018 | To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure Press Release Drug Trials Snapshot |
| 12. | Lokelma | sodium zirconium cyclosilicate | 5/18/2018 | To treat hyperkalemia Drug Trials Snapshot |
| 11. | Aimovig | erenumab-aooe | 5/17/2018 | For the preventive treatment for migraine Press Release Drug Trials Snapshot |
| 10. | Lucemyra | lofexidine hydrochloride | 5/16/2018 | For the non-opioid treatment for management of opioid withdrawal symptoms in adults Press Release Drug Trials Snapshot |
| 9. | Akynzeo | fosnetupitant and palonosetron | 4/19/2018 | To prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy Drug Trials Snapshot |
| 8. | Crysvita | burosumab-twza | 4/17/2018 | To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets Press Release Drug Trials Snapshot |
| 7. | Tavalisse | fostamatinib | 4/17/2018 | To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP) Drug Trials Snapshot |
| 6. | Ilumya | tildrakizumab | 3/20/2018 | To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy Drug Trials Snapshot |
| 5. | Trogarzo | ibalizumab-uiyk | 3/6/2018 | To treat HIV patients who have limited treatment options Press Release Drug Trials Snapshot |
| 4. | Erleada | apalutamide | 2/14/2018 | To treat a certain type of prostate cancer using novel clinical trial endpoint Press Release Drug Trials Snapshot |
| 3. | Symdeko | tezacaftor; ivacaftor | 2/12/2018 | To treat cystic fibrosis in patients age 12 years and older Drug Trials Snapshot |
| 2. | Biktarvy | bictegravir, embitcitabine, tenofovir alafenamide | 2/7/2018 | To treat infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen Drug Trials Snapshot |
| 1. | Lutathera | lutetium Lu 177 dotatate | 1/26/2018 | To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Press Release Drug Trials Snapshot |
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).