Summary of new drug Active Ingredients approved by the FDA in 2018

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

This page summarizes news about Novel Drug and Active Ingredients approved by FDA in 2018.

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.

January

• FDA approves new treatment (Lutathera) for certain digestive tract cancers

February

• FDA approves Apalutamide for non-metastatic castration-resistant prostate cancer
• FDA approves Biktarvy(bictegravir, embitcitabine, tenofovir alafenamide)
• FDA approves Symdek(Tezacaftor, ivacaftor)

March

• FDA approves Trogarzo(ibalizumab-uiyk)
• FDA approves Ilumya (tildrakizumab)

April

• FDA approves fostamatinib tablets for ITP
• FDA approves Crysvita (burosumab-twza)
• FDA approves Akynzeo (fosnetupitant, palonosetron)

May

• FDA approves Lucemyra ( lofexidine hydrochloride )
• FDA approves Aimovig ( erenumab-aooe )
• FDA approves Lokelma ( sodium zirconium cyclosilicate )
• FDA approves Doptelet ( avatrombopag )
• FDA approves Palynziq ( pegvaliase-pqpz )
• FDA approves Olumiant ( baricitinib )

June

• FDA approves Moxidectin
• FDA approves Epidiolex ( cannabidiol )
• FDA approves Zemdri ( plazomicin )
• FDA approves Mektovi ( binimetinib )
• FDA approves Braftovi ( encorafenib )

July

• FDA approves TPOXX ( tecovirimat )
• FDA approves Tibsovo ( ivosidenib )
• FDA approves Krintafel( tafenoquine)
• FDA approves Orilissa ( elagolix sodium )
• FDA approves Omegaven ( fish oil triglycerides )
• FDA approves Mulpleta ( lusutrombopag )
• FDA approves Xerava ( eravacycline )
• FDA approves Pifeltro ( doravirine )

August

• FDA approves Poteligeo ( mogamulizumab-kpkc )
• FDA approves Onpattro ( patisiran )
• FDA approves Annovera ( segesterone acetate and ethinyl estradiol vaginal system )
• FDA approves Galafold ( migalastat )
• FDA approves Diacomit ( stiripentol )
• FDA approves Oxervate ( cenegermin-bkbj )
• FDA approves Takhzyro ( lanadelumab )
• FDA approves Xerava ( eravacycline )
• FDA approves Pifeltro ( doravirine )

September

• FDA approves Lumoxiti ( moxetumomab pasudotox-tdfk )
• FDA approves Ajovy（fremanezumab-vfrm ）
• FDA approves Copiktra ( duvelisib )
• FDA approves Emgality ( galcanezumab-gnlm )
• FDA approves Vizimpro ( dacomitinib )
• FDA approves Libtayo ( cemiplimab-rwlc )

October

• FDA approves Seysara ( sarecycline )
• FDA approves Nuzyra ( omadacycline )
• FDA approves Revcovi ( elapegademase-lvlr )
• FDA approves Tegsedi ( inotersen )
• FDA approves Talzenna ( talazoparib )
• FDA approves Xofluza ( baloxavir marboxil )

November

• FDA approves Lorbrena ( lorlatinib )
• FDA approves Yupelri ( revefenacin )
• FDA approves Aemcolo ( rifamycin )
• FDA approves Gamifant ( emapalumab-lzsg )
• FDA approves Daurismo ( glasdegib )
• FDA approves Vitrakvi ( larotrectinib )
• FDA approves Firdapse ( amifampridine )
• FDA approves Xospata ( gilteritinib )

December

• FDA approves Motegrity ( prucalopride )
• FDA approves Asparlas ( calaspargase pegol-mknl )
• FDA approves Elzonris ( tagraxofusp-erzs )
• FDA approves Ultomiris ( ravulizumab )

Expands approval

• FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
• FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
• FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse