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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 |
|
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 |
|
|
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 |
|
|
Tezacaftor; Ivacaftor |
2/13/2018 |
To treat cystic fibrosis in patients age 12 years and older; Drug Trials Snapshot |
|
|
Apalutamide |
2/14/2018 |
To treat a certain type of prostate cancer using novel clinical trial endpoint; Press Release, Drug Trials Snapshot |
|
|
Ibalizumab-Uiyk |
3/6/2018 |
To treat HIV patients who have limited treatment options; Press Release, Drug Trials Snapshot |
|
|
Tildrakizumab |
3/20/2018 |
To treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy; Drug Trials Snapshot |
|
|
Fostamatinib |
4/17/2018 |
To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP); Drug Trials Snapshot |
|
|
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 |
|
|
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 |
|
|
Lofexidine Hydrochloride |
5/16/2018 |
For the non-opioid treatment for management of opioid withdrawal symptoms in adults; Press Release, Drug Trials Snapshot |
|
|
Erenumab-Aooe |
5/17/2018 |
For the preventive treatment for migraine; Press Release, Drug Trials Snapshot |
|
|
Sodium Zirconium Cyclosilicate |
5/18/2018 |
To treat hyperkalaemia; Drug Trials Snapshot |
|
|
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 |
|
|
Pegvaliase-Pqpz |
5/24/2018 |
To treat adults with a rare and serious genetic disease known as phenylketonuria (PKU); Press Release, Drug Trials Snapshot |
|
|
Baricitinib |
5/31/2018 |
To treat moderately to severely active rheumatoid arthritis; Drug Trials Snapshot |
|
|
Moxidectin |
6/13/2018 |
To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older; Drug Trials Snapshot |
|
|
Cannabidiol |
6/25/2018 |
To treat rare, severe forms of epilepsy; Press Release, Drug Trials Snapshot |
|
|
Plazomicin |
6/25/2018 |
To treat adults with complicated urinary tract infections; Drug Trials Snapshot |
|
|
Binimetinib |
6/27/2018 |
To treat unrespectable or metastatic melanoma |
|
|
Encorafenib |
6/27/2018 |
To treat unrespectable or metastatic melanoma FDA Announcement; Drug Trials Snapshot |
|
|
Tecovirimat |
7/13/2018 |
To treat smallpox; Press Release, Drug Trials Snapshot |
|
|
Ivosidenib |
7/20/2018 |
To treat patients with relapsed or refractory acute myeloid leukemia ; Press Release, Drug Trials Snapshot |
|
|
Tafenoquine |
7/20/2018 |
For the radical cure (prevention of relapse) of Plasmodium vivax malaria; Drug Trials Snapshot |
|
|
Elagolix Sodium |
7/23/2018 |
For the management of moderate to severe pain associated with endometriosis; Drug Trials Snapshot |
|
|
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 |
|
|
Lusutrombopag |
7/31/2018 |
To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure; Drug Trials Snapshot |
|
|
Mogamulizumab-Kpkc |
8/8/2018 |
To treat two rare types of non-Hodgkin lymphoma; Press Release, Drug Trials Snapshot |
|
|
Patisiran |
8/10/2018 |
To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients; Press Release, Drug Trials Snapshot |
|
|
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 |
|
|
Migalastat |
8/10/2018 |
To treat treat adults with Fabry disease. Press Release; Drug Trials Snapshot |
|
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Stiripentol |
8/20/2018 |
To treat seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam; Drug Trials Snapshot |
|
|
Cenegermin-Bkbj |
8/22/2018 |
To treat neurotrophic keratitis; Press Release, Drug Trials Snapshot |
|
|
Lanadelumab |
8/23/2018 |
To treat types I and II hereditary angioedema; Drug Trials Snapshot |
|
|
Eravacycline |
8/27/2018 |
To treat complicated intra-abdominal infections in patients 18 years of age and older |
|
|
Doravirine |
8/30/2018 |
To treat HIV-1 infection in adult patients |
|
|
Moxetumomab Pasudotox-Tdfk |
9/13/2018 |
To treat hairy cell leukemia; Press Release , Drug Trials Snapshot |
|
|
Fremanezumab-Vfrm |
9/14/2018 |
For the preventive treatment of migraine in adults; Drug Trials Snapshot |
|
|
Duvelisib |
9/24/2018 |
To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma; Drug Trials Snapshot |
|
|
Galcanezumab-Gnlm |
9/27/2018 |
For the preventive treatment of migraine in adults; Drug Trials Snapshot |
|
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Dacomitinib |
9/27/2018 |
To treat metastatic non-small-cell lung cancer; Drug Trials Snapshot |
|
|
Cemiplimab-Rwlc |
9/28/2018 |
To treat cutaneous squamous cell carcinoma (CSCC) ; Press Release, Drug Trials Snapshot |
|
|
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 |
|
|
Omadacycline |
10/3/2018 |
To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections; Drug Trials Snapshot |
|
|
Elapegademase-Lvlr |
10/5/2018 |
To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID); Drug Trials Snapshot |
|
|
Inotersen |
10/5/2018 |
To treat polyneuropathy of here-ditary transthyretin mediated amyloidosis in adults; Drug Trials Snapshot |
|
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Talazoparib |
10/16/2018 |
For the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation. Drug Trials Snapshot |
|
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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 |
|
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Lorlatinib |
11/2/2018 |
To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer |
|
|
Revefenacin |
11/8/2018 |
To treat patients with chronic obstructive pulmonary disease (COPD); Drug Trials Snapshot |
|
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Rifamycin |
11/16/2018 |
To treat travelers’ diarrhea; Press Release, Drug Trials Snapshot |
|
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Emapalumab-Lzsg |
11/20/2018 |
To treat primary hemophagocytic lymphohistiocytosis (HLH); Press Release, Drug Trials Snapshot |
|
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Glasdegib |
11/21/2018 |
To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients; Press Release , Drug Trials Snapshot |
|
|
Larotrectinib |
11/26/2018 |
To treat patients whose cancers have a specific genetic feature (biomarker); Press Release, Drug Trials Snapshot |
|
|
Amifampridine |
11/28/2018 |
To treat Lambert-Eaton myasthenic syndrome (LEMS) in adults; Press Release, Drug Trials Snapshot |
|
|
Gilteritinib |
11/28/2018 |
To treat patients who have relapsed or refractory acute myeloid leukemia (AML); Press Release, Drug Trials Snapshot |
|
|
Prucalopride |
12/14/2018 |
To treat chronic idiopathic constipation; Drug Trials Snapshot |
|
|
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 |
|
|
Tagraxofusp-Erzs |
12/21/2018 |
To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN); Press Release, Drug Trials Snapshot. |
|
|
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
Name: Zubair Khalid Labu, Jalal Uddin, Md. Mostafizur Rahaman
Department of Pharmacy
20 February, 2019
