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     

Source: FDA – CDER

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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