FDA- Approved New Drugs for 2018

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.

Table: List of New drug Approvals for 2018

Market product name

Generic Name

Drug approvals Date

Medicinal Uses

Lutathera

Lutetium Lu 177 Dotatate

1/26/2018

To treat a type of cancer that affects the pancreas or gastro-intestinal tract called gastroentero- pancreatic neuroendocrine tumors (GEP-NETs). Press Release, Drug Trials Snapshot

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

Symdeko

Tezacaftor; Ivacaftor

2/13/2018

To treat cystic fibrosis in patients age 12 years and older; Drug Trials Snapshot

Erleada

Apalutamide

2/14/2018

To treat a certain type of prostate cancer using novel clinical trial endpoint; Press Release, Drug Trials Snapshot

Trogarzo

Ibalizumab-Uiyk

3/6/2018

To treat HIV patients who have limited treatment options; Press Release, Drug Trials Snapshot

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

Tavalisse

Fostamatinib

4/17/2018

To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP); Drug Trials Snapshot

Crysvita

Burosumab-Twza

4/17/2018

To treat adults and children ages 1 year and older with x-linked hypo-phosphatemia (XLH), a rare, inherited form of rickets; Press Release, Drug Trials Snapshot

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

Lucemyra

Lofexidine Hydrochloride

5/16/2018

For the non-opioid treatment for management of opioid withdrawal symptoms in adults; Press Release, Drug Trials Snapshot

Aimovig

Erenumab-Aooe

5/17/2018

For the preventive treatment for migraine; Press Release, Drug Trials Snapshot

Lokelma

Sodium Zirconium Cyclosilicate

5/18/2018

To treat hyperkalaemia; Drug Trials Snapshot

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

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

Olumiant

Baricitinib

5/31/2018

To treat moderately to severely active rheumatoid arthritis; Drug Trials Snapshot

Moxidectin

Moxidectin

6/13/2018

To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older; Drug Trials Snapshot

Epidiolex

Cannabidiol

6/25/2018

To treat rare, severe forms of epilepsy; Press Release, Drug Trials Snapshot

Zemdri

Plazomicin

6/25/2018

To treat adults with complicated urinary tract infections; Drug Trials Snapshot

Mektovi

Binimetinib

6/27/2018

To treat unrespectable or metastatic melanoma 
FDA Announcement; Drug Trials Snapshot

Braftovi

Encorafenib

6/27/2018

To treat unrespectable or metastatic melanoma  FDA Announcement; Drug Trials Snapshot

TPOXX

Tecovirimat

7/13/2018

To treat smallpox; Press Release, Drug Trials Snapshot

Tibsovo

Ivosidenib

7/20/2018

To treat patients with relapsed or refractory acute myeloid leukemia ; Press Release, Drug Trials Snapshot

Krintafel

Tafenoquine

7/20/2018

For the radical cure (prevention of relapse) of Plasmodium vivax malaria; Drug Trials Snapshot

Orilissa

Elagolix Sodium

7/23/2018

For the management of moderate to severe pain associated with endometriosis; Drug Trials Snapshot

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

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

Poteligeo

Mogamulizumab-Kpkc

8/8/2018

To treat two rare types of non-Hodgkin lymphoma; Press Release, Drug Trials Snapshot

Onpattro

Patisiran

8/10/2018

To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients; Press Release, Drug Trials Snapshot

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

Galafold

Migalastat

8/10/2018

To treat treat adults with Fabry disease. Press Release; Drug Trials Snapshot

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

Oxervate

Cenegermin-Bkbj

8/22/2018

To treat neurotrophic keratitis; Press Release, Drug Trials Snapshot

Takhzyro

Lanadelumab

8/23/2018

To treat types I and II hereditary angioedema;  Drug Trials Snapshot

Xerava

Eravacycline

8/27/2018

To treat complicated intra-abdominal infections in patients 18 years of age and older

Pifeltro

Doravirine

8/30/2018

To treat HIV-1 infection in adult patients
Drug Trials Snapshot

Lumoxiti

Moxetumomab Pasudotox-Tdfk

9/13/2018

To treat hairy cell leukemia; Press Release , Drug Trials Snapshot

Ajovy

Fremanezumab-Vfrm

9/14/2018

For the preventive treatment of migraine in adults; Drug Trials Snapshot

Copiktra

Duvelisib

9/24/2018

To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma; Drug Trials Snapshot

Emgality

Galcanezumab-Gnlm

9/27/2018

For the preventive treatment of migraine in adults; Drug Trials Snapshot

Vizimpro

Dacomitinib

9/27/2018

To treat metastatic non-small-cell lung cancer; Drug Trials Snapshot

Libtayo

Cemiplimab-Rwlc

9/28/2018

To treat cutaneous squamous cell carcinoma (CSCC) ; Press Release, Drug Trials Snapshot

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

Nuzyra

Omadacycline

10/3/2018

To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections; Drug Trials Snapshot

Revcovi

Elapegademase-Lvlr

10/5/2018

To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID); Drug Trials Snapshot

Tegsedi

Inotersen

10/5/2018

To treat polyneuropathy of here-ditary transthyretin mediated amyloidosis in adults; Drug Trials Snapshot

Talzenna

Talazoparib

10/16/2018

For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.  Drug Trials Snapshot 

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. Press Release, Drug Trials Snapshot

Lorbrena

Lorlatinib

11/2/2018

To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Drug Trials Snapshot

Yupelri

Revefenacin

11/8/2018

To treat patients with chronic obstructive pulmonary disease (COPD); Drug Trials Snapshot

Aemcolo

Rifamycin

11/16/2018

To treat travelers’ diarrhea; Press Release, Drug Trials Snapshot

Gamifant

Emapalumab-Lzsg

11/20/2018

To treat primary hemophagocytic lymphohistiocytosis (HLH); Press Release, Drug Trials Snapshot

Daurismo

Glasdegib

11/21/2018

To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients; Press Release , Drug Trials Snapshot

Vitrakvi

Larotrectinib

11/26/2018

To treat patients whose cancers have a specific genetic feature (biomarker); Press Release, Drug Trials Snapshot

Firdapse

Amifampridine

11/28/2018

To treat  Lambert-Eaton myasthenic syndrome (LEMS) in adults; Press Release, Drug Trials Snapshot

Xospata

Gilteritinib

11/28/2018

To treat patients who have relapsed or refractory acute myeloid leukemia (AML); Press Release, Drug Trials Snapshot

Motegrity

Prucalopride

12/14/2018

To treat chronic idiopathic constipation; Drug Trials Snapshot

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

Elzonris

Tagraxofusp-Erzs

12/21/2018

To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN); Press Release, Drug Trials Snapshot.

Ultomiris

Ravulizumab

12/21/2018

To treat paroxysmal nocturnal hemoglobinuria (PNH); 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.

*Sources: Internet

 

Zubair Khalid Labu, Jalal Uddin, Md. Mostafizur Rahaman
Department of Pharmacy
World University of Bangladesh