|
Approval Date |
Brand Name |
Generic Name |
Indication: |
Comments related to Primary Care: |
|
1/26/2018 |
Lutathera |
lutetium Lu 177 dotatate |
To treat a type of cancer that affects the
pancreas or gastrointestinal tract called gastroenteropancreatic
neuroendocrine tumors (GEP-NETs). |
|
|
2/7/2018 |
Biktarvy |
bictegravir, embitcitabine, tenofovir
alafenamide |
To treat infection in adults who have no
antiretroviral treatment history or to replace the current antiretroviral
regimen |
NEW COMBO PROUCT for HIV |
|
2/13/2018 |
Symdeko |
tezacaftor; ivacaftor |
To treat cystic fibrosis in patients age 12
years and older |
|
|
2/14/2018 |
Erleada |
apalutamide |
To treat a certain type of prostate cancer
using novel clinical trial endpoint |
|
|
3/6/2018 |
Trogarzo |
ibalizumab-uiyk |
To treat HIV patients who have limited
treatment options |
|
|
3/20/2018 |
Ilumya |
tildrakizumab |
To treat adults with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or phototherapy |
|
|
4/17/2018 |
Tavalisse |
fostamatinib |
To treat thrombocytopenia in adult patients
with persistent or chronic immune thrombocytopenia (ITP) |
|
|
4/17/2018 |
Crysvita |
burosumab-twza |
To treat adults and children ages 1 year and
older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets |
|
|
4/19/2018 |
Akynzeo |
fosnetupitant and palonosetron |
To prevent acute and delayed nausea and
vomiting associated with initial and repeat courses of highly emetogenic
cancer chemotherapy |
|
|
5/16/2018 |
Lucemyra |
lofexidine hydrochloride |
For the non-opioid treatment for management of
opioid withdrawal symptoms in adults.
Alpha-2 agonist |
Dose: 3 tabs po QID for up to 14 days. Common
ADRs: hypotension, bradycardia, dizziness, somnolence, dry mouth |
|
5/17/2018 |
Aimovig |
erenumab-aooe |
For the preventive treatment for migraine |
Dose: Subcutaneous via auto-injector once a
month. Most common ADRs: injection
site reactions and constipation. |
|
5/18/2018 |
Lokelma |
sodium zirconium cyclosilicate |
To treat hyperkalemia |
Dose: 10 gm TID (oral suspension in
packets) for 48 hours then once
daily. Common ADRs: edema and binding
to other meds |
|
5/21/2018 |
Doptelet |
avatrombopag |
To treat low blood platelet count
(thrombocytopenia) in adults with chronic liver disease who are scheduled to
undergo a medical or dental procedure |
|
|
5/24/2018 |
Palynziq |
pegvaliase-pqpz |
To treat adults with a rare and serious
genetic disease known as phenylketonuria (PKU) |
|
|
5/31/2018 |
Olumiant |
baricitinib |
To treat moderately to severely active
rheumatoid arthritis |
|
|
6/13/2018 |
Moxidectin |
moxidectin |
To treat onchocerciasis due to Onchocerca
volvulus in patients aged 12 years and older |
|
|
6/25/2018 |
Epidiolex |
cannabidiol |
To treat rare, severe forms of epilepsy |
Neuro: CBD oral solution - the first
Cannibidiol product |
|
6/25/2018 |
Zemdri |
plazomicin |
To treat adults with complicated urinary tract
infections (aminoglycoside) |
Dose: Once daily IV treatment |
|
6/27/2018 |
Mektovi |
binimetinib |
To treat unresectable or metastatic melanoma |
|
|
6/27/2018 |
Braftovi |
encorafenib |
To treat unresectable or metastatic melanoma |
|
|
7/13/2018 |
TPOXX |
tecovirimat |
To treat smallpox |
|
|
7/20/2018 |
Tibsovo |
ivosidenib |
To treat patients with relapsed or refractory
acute myeloid leukemia |
|
|
7/20/2018 |
Krintafel |
tafenoquine |
For the radical cure (prevention of relapse)
of Plasmodium vivax malaria |
|
|
7/23/2018 |
Orilissa |
elagolix sodium |
For the management of moderate to severe pain
associated with endometriosis |
Dose: Once daily oral formulation for up to 6
months. Common ADRs: hot flushes/night sweats, headache, nausea, insomnia,
amenorrhea, anxiety, arthralgia, depression |
|
7/27/2018 |
Omegaven |
fish oil triglycerides |
As a source of calories and fatty acids in
pediatric patients with parenteral nutrition-associated cholestasis |
|
|
7/31/2018 |
Mulpleta |
lusutrombopag |
To treat thrombocytopenia in adult patients
with chronic liver disease who are scheduled to undergo a procedure |
|
|
8/8/2018 |
Poteligeo |
mogamulizumab-kpkc |
To treat two rare types of non-Hodgkin
lymphoma |
|
|
8/10/2018 |
Onpattro |
patisiran |
To treat the polyneuropathy of hereditary
transthyretin-mediated amyloidosis in adult patients |
|
|
8/10/2018 |
Annovera |
segesterone acetate and ethinyl estradiol
vaginal system |
New vaginal ring used to prevent pregnancy
for an entire year |
Dose: insert ring into vagina and keep in
place for 3 weeks, followed by 1 week off.
Re-insert for the next cycle. 1 insert is good for 13 cycles. Common ADRs: similar to other
contraceptives: headache/migraine, N/V, bleeding irrigularities, risk of
thromboembolic events. |
|
8/10/2018 |
Galafold |
migalastat |
To treat treat adults with Fabry disease. |
|
|
8/20/2018 |
Diacomit |
stiripentol |
To treat seizures associated with Dravet
syndrome in patients 2 years of age and older taking clobazam |
|
|
8/22/2018 |
Oxervate |
cenegermin-bkbj |
To treat neurotrophic keratitis |
|
|
8/23/2018 |
Takhzyro |
lanadelumab |
To treat types I and II hereditary angioedema |
|
|
8/27/2018 |
Xerava |
eravacycline |
To treat complicated intra-abdominal
infections in patients 18 years of age and older (Tetracycline class) |
|
|
8/30/2018 |
Pifeltro |
doravirine |
To treat HIV-1 infection in adult patients |
|
|
9/13/2018 |
Lumoxiti |
moxetumomab pasudotox-tdfk |
To treat hairy cell leukemia |
|
|
9/14/2018 |
Ajovy |
fremanezumab-vfrm |
For the preventive treatment of migraine in
adults |
Dose: Subcutaneous via auto-injector once a
month or quarterly (higher dose) Most
common ADRs: injection site reactions. |
|
9/24/2018 |
Copiktra |
duvelisib |
To treat relapsed or refractory chronic
lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma |
|
|
9/27/2018 |
Emgality |
galcanezumab-gnlm |
For the preventive treatment of migraine in
adults |
Dose: Subcutaneous prefilled syringe. Loading dose w/2 injections followed by
monthly dose. Common ADRs: injection site reactions |
|
9/27/2018 |
Vizimpro |
dacomitinib |
To treat metastatic non-small-cell lung cancer |
|
|
9/28/2018 |
Libtayo |
cemiplimab-rwlc |
To treat cutaneous squamous cell carcinoma
(CSCC) |
|
|
10/1/2018 |
Seysara |
sarecycline |
To treat inflammatory lesions of non-nodular
moderate to severe acne vulgaris in patients 9 years of age and older (Tetracycline
class) |
Dose: Once daily oral formulation. Common ADR:
Nausea, rare CNS effects |
|
10/3/2018 |
Nuzyra |
omadacycline |
To treat community-acquired bacterial
pneumonia and acute bacterial skin and skin structure infections.
(Tetracycline class) |
Dose: available in both IV and Oral dosage
forms. After loading dose, maintenance
dose is once daily for 7 to 14 days. |
|
10/5/2018 |
Revcovi |
elapegademase-lvlr |
To treat Adenosine Deaminase-Severe Combined
Immunodeficiency (ADA-SCID) |
|
|
10/5/2018 |
Tegsedi |
inotersen |
To treat polyneuropathy of hereditary
transthyretin-mediated amyloidosis in adults |
|
|
10/16/2018 |
Talzenna |
talazoparib |
For the treatment of locally advanced or
metastatic breast cancer patients with a germline BRCA mutation. |
|
|
10/24/2018 |
Xofluza |
baloxavir marboxil |
For the treatment of acute uncomplicated
influenza in patients who have been symptomatic for no more than 48 hours. |
Dose: single oral dose within 48 hours of
onset of influenza. Common ADRs:
diarrhea, bronchitis/nasopharyngitis, headach, nausea |
|
11/2/2018 |
Lorbrena |
lorlatinib |
To treat patients with anaplastic lymphoma
kinase (ALK)-positive metastatic non-small cell lung cancer |
|
|
11/8/2018 |
Yupelri |
revefenacin |
To treat patients with chronic obstructive
pulmonary disease (COPD). Anticholinergic inhalation soln for maintenance
treatment |
Dose: once daily inhalation via nebulizer.
Common ADRs: cough/nasopharyngitis, URI, headache, back pain |
|
11/16/2018 |
Aemcolo |
rifamycin |
To treat travelers’ diarrhea caused by
non-invasive E. coli |
Dose: Take BID for 3 days. Avoid in patients with diarrhea complicated
by fever and/or bloody stool. Most common ADRs: headache and constipation |
|
11/20/2018 |
Gamifant |
emapalumab-lzsg |
To treat primary hemophagocytic
lymphohistiocytosis (HLH) |
|
|
11/21/2018 |
Daurismo |
glasdegib |
To treat newly-diagnosed acute myeloid
leukemia (AML) in adult patients |
|
|
11/26/2018 |
Vitrakvi |
larotrectinib |
To treat patients whose cancers have a
specific genetic feature (biomarker) |
|
|
11/28/2018 |
Firdapse |
amifampridine |
To treat Lambert-Eaton myasthenic
syndrome (LEMS) in adults |
|
|
11/28/2018 |
Xospata |
gilteritinib |
To treat patients who have relapsed or
refractory acute myeloid leukemia (AML) |
|
|
5/3/2018 |
Andexxa |
coagulation factor Xa |
anticoagulation reversal agent for rivaroxaban
and apixaban |
|
|
BIOSIMILARS APPROVED IN 2018: |
|
Fulphila |
pegfilgrastim-jmdb |
Biosimilar to Neulasta |
|
|
Hyrimoz |
adalimumab-adaz |
Biosimilar to Humira |
|
|
Retacrit |
epoetin alfa-epbx |
Biosimilar to Epogen/Procrit |
|
|
Truxima |
rituximab-abbs |
Biosimilar to Rituxan |
|
|
Udenyca |
pegfilgrastim-cbqv |
Biosimilar to Neulasta |
|
