Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment. To do so, CDER relies on 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.
Each year, CDER approves a wide range of new drugs and biological products:
- Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022.
- Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, 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 FDA has previously approved. 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.
|No.||Drug Name||Active Ingredient||Approval Date||FDA-approved use on approval date*|
To delay the onset of stage 3 type 1 diabetes
To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
|28.||Tecvayli||teclistamab-cqyv||10/25/2022||To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy|
|27.||Imjudo||tremelimumab||10/21/2022||To treat unresectable hepatocellular carcinoma|
To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements
To treat amyotrophic lateral sclerosis (ALS)
|24.||Omlonti||oomidenepag isopropyl ophthalmic solution||9/22/2022||To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension|
|23.||Elucirem||gadopiclenol||9/21/2022||To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body|
|22.||Terlivaz||terlipressin||9/14/2022||To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function|
|21.||Rolvedon||eflapegrastim||9/9/2022||To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia|
|20.||Sotyktu||deucravacitinib||9/9/2022||To treat moderate-to-severe plaque psoriasis|
|19.||Daxxify||daxibotulinumtoixnA-lanm||9/7/2022||To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity|
|18.||Spevigo||spesolimab-sbzo||9/1/2022||To treat generalized pustular psoriasis flares|
|17.||Xenpozyme||Olipudase alfa||8/31/2022||To treat Acid Sphingomyelinase Deficiency
To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
|15.||Vtama||tapinarof||5/23/2022||To treat plaque psoriasis|
|14.||Mounjaro||tirzepatide||5/13/2022||To improve blood sugar control in diabetes, in addition to diet and exercise
|13.||Voquezna||vonoprazan, amoxicillin, and clarithromycin||5/3/2022||To treat Helicobacter pylori infection|
|12.||Camzyos||mavacamten||4/28/2022||To treat certain classes of obstructive hypertrophic cardiomyopathy|
|11.||Vivjoa||oteseconazole||4/26/2022||To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential|
|10.||Pluvicto||lutetium (177Lu) vipivotide tetraxetan||3/23/2022||To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies|
|9.||Opdualag||nivolumab and relatlimab-rmbw||3/18/2022||To treat unresectable or metastatic melanoma|
|8.||Ztalmy||ganaxolone||3/18/2022||To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder|
|7.||Vonjo||pacritinib||2/28/2022||To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets|
|6.||Pyrukynd||mitapivat||2/17/2022||To treat hemolytic anemia in pyruvate kinase deficiency|
|5.||Enjaymo||sutimlimab-jome||2/4/2022||To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease|
|4.||Vabysmo||faricimab-svoa||1/28/2022||To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema|
|3.||tebentafusp-tebn||1/25/2022||To treat unresectable or metastatic uveal melanoma|
|2.||Cibinqo||abrocitinib||1/14/2022||To treat refractory, moderate-to-severe atopic dermatitis|
|1.||Quviviq||daridorexant||1/7/2022||To treat insomnia|
*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent FDA-approved Prescribing Information (click on the Drug Name).