FDA – New Drug Approvals from 2009 to 2018
Total New Drugs were approved by FDA in last 10 years – 356
The maximum number of New Drug Approvals – In 2018 with a total 59 New Drugs Approved.
Average number of Drugs approved in last 10 years – 33 per year
FDA – New Drug Approvals for 2018
| 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) |
| 58 | Elzonris | tagraxofusp-erzs | 12/21/2018 |
To treat
blastic plasmacytoid dendritic cell neoplasm (BPDCN) |
| 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 |
| 56 | Motegrity | prucalopride | 12/14/2018 |
To treat
chronic idiopathic constipation |
| 55 | Xospata | gilteritinib | 11/28/2018 |
To treat
patients who have relapsed or refractory acute myeloid leukemia (AML) |
| 54 | Firdapse | amifampridine | 11/28/2018 |
To
treat Lambert-Eaton myasthenic syndrome (LEMS) in adults |
| 53 | Vitrakvi | larotrectinib | 11/26/2018 |
To treat
patients whose cancers have a specific genetic feature (biomarker) |
| 52 | Daurismo | glasdegib | 11/21/2018 |
To treat
newly-diagnosed acute myeloid leukemia (AML) in adult patients |
| 51 | Gamifant | emapalumab-lzsg | 11/20/2018 |
To treat
primary hemophagocytic lymphohistiocytosis (HLH) |
| 50 | Aemcolo | rifamycin | 11/16/2018 | To treat travelers’ diarrhea |
| 49 | Yupelri | revefenacin | 11-08-2018 |
To treat
patients with chronic obstructive pulmonary disease (COPD) |
| 48 | Lorbrena | lorlatinib | 11-02-2018 |
To
treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer |
| 47 | Xofluza | baloxavir marboxil | 10/24/2018 |
For the
treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours. |
| 46 | Talzenna | talazoparib | 10/16/2018 |
For the
treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation. |
| 45 | Tegsedi | inotersen | 10-05-2018 |
To treat
polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
| 44 | Revcovi | elapegademase-lvlr | 10-05-2018 |
To treat
Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID) |
| 43 | Nuzyra | omadacycline | 10-03-2018 |
To treat
community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections |
| 42 | Seysara | sarecycline | 10-01-2018 |
To treat
inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older |
| 41 | Libtayo | cemiplimab-rwlc | 9/28/2018 |
To treat
cutaneous squamous cell carcinoma (CSCC) |
| 40 | Vizimpro | dacomitinib | 9/27/2018 |
To treat
metastatic non-small-cell lung cancer |
| 39 | Emgality | galcanezumab-gnlm | 9/27/2018 |
For the
preventive treatment of migraine in adults |
| 38 | Copiktra | duvelisib | 9/24/2018 |
To
treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma |
| 37 | Ajovy | fremanezumab-vfrm | 9/14/2018 | For the preventive treatment of migraine in adults |
| 36 | Lumoxiti | moxetumomab pasudotox-tdfk | 9/13/2018 | To treat hairy cell leukemia |
| 35 | Pifeltro | doravirine | 8/30/2018 |
To treat
HIV-1 infection in adult patients |
| 34 | Xerava | eravacycline | 8/27/2018 |
To treat
complicated intra-abdominal infections in patients 18 years of age and older |
| 33 | Takhzyro | lanadelumab | 8/23/2018 |
To treat
types I and II hereditary angioedema |
| 32 | Oxervate | cenegermin-bkbj | 8/22/2018 | To treat neurotrophic keratitis |
| 31 | Diacomit | stiripentol | 8/20/2018 |
To treat
seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam |
| 30 | Galafold | migalastat | 08-10-2018 |
To treat
treat adults with Fabry disease. |
| 29 | Annovera |
segesterone
acetate and ethinyl estradiol vaginal system | 08-10-2018 |
New
vaginal ring used to prevent pregnancy for an entire year |
| 28 | Onpattro | patisiran | 08-10-2018 |
To
treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients |
| 27 | Poteligeo | mogamulizumab-kpkc | 08-08-2018 |
To treat
two rare types of non-Hodgkin lymphoma |
| 26 | Mulpleta | lusutrombopag | 7/31/2018 |
To treat
thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure |
| 25 | Omegaven | fish oil triglycerides | 7/27/2018 |
As a
source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis |
| 24 | Orilissa | elagolix sodium | 7/23/2018 |
For the
management of moderate to severe pain associated with endometriosis |
| 23 | Krintafel | tafenoquine | 7/20/2018 |
For the
radical cure (prevention of relapse) of Plasmodium vivax malaria |
| 22 | Tibsovo | ivosidenib | 7/20/2018 |
To treat
patients with relapsed or refractory acute myeloid leukemia |
| 21 | TPOXX | tecovirimat | 7/13/2018 | To treat smallpox |
| 20 | Braftovi | encorafenib | 6/27/2018 |
To treat
unresectable or metastatic melanoma |
| 19 | Mektovi | binimetinib | 6/27/2018 |
To treat
unresectable or metastatic melanoma |
| 18 | Zemdri | plazomicin | 6/25/2018 |
To treat
adults with complicated urinary tract infections |
| 17 | Epidiolex | cannabidiol | 6/25/2018 |
To treat
rare, severe forms of epilepsy |
| 16 | Moxidectin | moxidectin | 6/13/2018 |
To treat
onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older |
| 15 | Olumiant | baricitinib | 5/31/2018 |
To treat
moderately to severely active rheumatoid arthritis |
| 14 | Palynziq | pegvaliase-pqpz | 5/24/2018 |
To
treat adults with a rare and serious genetic disease known as phenylketonuria (PKU) |
| 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 |
| 12 | Lokelma |
sodium
zirconium cyclosilicate | 5/18/2018 | To treat hyperkalemia |
| 11 | Aimovig | erenumab-aooe | 5/17/2018 |
For the
preventive treatment for migraine |
| 10 | Lucemyra | lofexidine hydrochloride | 5/16/2018 |
For the non-opioid
treatment for management of opioid withdrawal symptoms in adults |
| 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 |
| 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 |
| 7 | Tavalisse | fostamatinib | 4/17/2018 |
To treat
thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP) |
| 6 | Ilumya | tildrakizumab | 3/20/2018 |
To treat
adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy |
| 5 | Trogarzo | ibalizumab-uiyk | 03-06-2018 |
To treat
HIV patients who have limited treatment options |
| 4 | Erleada | apalutamide | 2/14/2018 |
To treat
a certain type of prostate cancer using novel clinical trial endpoint |
| 3 | Symdeko | tezacaftor; ivacaftor | 2/13/2018 |
To treat
cystic fibrosis in patients age 12 years and older |
| 2 | Biktarvy |
bictegravir,
embitcitabine, tenofovir alafenamide | 02-07-2018 |
To treat
infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen |
| 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). |
Reference: USFDA
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