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  5. Novel Drug Approvals for 2018
  1. Development & Approval Process (Drugs)

Novel Drug Approvals for 2018

Novel Drug Approvals for 2018

2018 New Approvals Report Cover

2018 New Approvals Report (PDF - 2 MB)
Text Version

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, FDA 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.

Each year, CDER approves a wide range of new drugs and biological products. Some of these products are innovative new products that never before have been used in clinical practice. Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace.

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
Drug Trials Snapshot for bacterial skin infections
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
More Information
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
FDA Announcement
Drug Trials Snapshot
19. Mektovi binimetinib 6/27/2018 To treat unresectable or metastatic melanoma
FDA Announcement
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

* This information is currently accurate. In rare instances, it may be necessary for FDA to change a drug’s new molecular entity (NME) designation or the status of its application as a novel new biologics license application (BLA).  For instance, new information may become available which could lead to a reconsideration of the original designation or status.  If changes must be made to a drug’s designation or the status of an application as a novel BLA, the Agency intends to communicate the nature of, and the reason for, any revisions as appropriate.

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