29 December 2023 | Friday | News
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:
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* |
---|---|---|---|---|
55. | Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
54. | Filsuvez | birch triterpenes | 12/18/2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa |
53. | Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
52. | Ogsiveo | nirogacestat | 11/27/2023 | To treat adults with progressing desmoid tumors who require systemic treatment |
51. | Truqap | capivasertib | 11/16/2023 | To treat breast cancer that meets certain disease criteria |
50. | Ryzneuta | efbemalenograstim alfa-vuxw | 11/16/2023 | To treat neutropenia |
49. | Augtyro | repotrectinib | 11/15/2023 | To treat ROS1-positive non-small cell lung cancer |
48. | Defencath | taurolidine, heparin | 11/15/2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter |
47. | Fruzaqla | fruquintinib | 11/8/2023 | To treat refractory, metastatic colorectal cancer |
46. | Loqtorzi | toripalimab-tpzi | 10/27/2023 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies |
45. | Omvoh | mirikizumab-mrkz | 10/26/2023 | To treat ulcerative colitis |
44. | Agamree | vamorolone | 10/26/2023 | To treat Duchenne muscular dystrophy |
43. | Bimzelx | bimekizumab | 10/17/2023 | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
42. | Zilbrysq | zilucoplan | 10/17/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive |
41. | Velsipity | etrasimod | 10/12/2023 | To treat moderately to severely active ulcerative colitis in adults |
40. | Rivfloza | nedosiran | 9/29/2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function |
39. | Pombiliti | cipaglucosidase alfa-atga | 9/28/2023 | To treat late-onset Pompe disease |
38. | Exxua | gepirone | 9/22/2023 | To treat major depressive disorder |
37. | Ojjaara | momelotinib | 9/15/2023 | To treat intermediate or high-risk myelofibrosis in adults with anemia |
36. | Aphexda | motixafortide | 9/8/2023 | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma |
35. | Veopoz | pozelimab-bbfg | 8/18/2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease |
34. | Sohonos | palovarotene | 8/16/2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva |
33. | Elrexfio | elranatamab-bcmm | 8/14/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy |
32. | Talvey | talquetamab-tgvs | 8/9/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies |
31. | Izervay | avacincaptad pegol | 8/4/2023 | To treat geographic atrophy secondary to age-related macular degeneration |
30. | Zurzuvae | zuranolone | 8/4/2023 | To treat postpartum depression Press Release |
29. | Xdemvy | lotilaner | 7/25/2023 | To treat Demodex blepharitis |
28. | Vanflyta | quizartinib | 7/20/2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria |
27. | Beyfortus | nirsevimab-alip | 7/17/2023 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease Press Release |
26. | Ngenla | somatrogon-ghla | 6/27/2023 | To treat growth failure due to inadequate secretion of endogenous growth hormone |
25. | Rystiggo | rozanolixizumab-noli | 6/26/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive |
24. | Litfulo | ritlecitinib | 6/23/2023 | To treat severely patchy hair loss |
23. | Columvi | glofitamab-gxbm | 6/15/2023 | To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy |
22. | Inpefa | sotagliflozin | 5/26/2023 |
To treat heart failure |
21. | Posluma | flotufolastat F 18 | 5/25/2023 | To use with positron emission tomography imaging in certain patients with prostate cancer |
20. | Paxlovid | nirmatrelvir, ritonavir | 5/25/2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 Press Release |
19. | Xacduro | sulbactam, durlobactam | 5/23/2023 |
To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex |
18. | Epkinly | epcoritamab-bysp | 5/19/2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy |
17. | Miebo | perfluorhexyloctane | 5/18/2023 | To treat signs and symptoms of dry eye disease |
16. | Veozah | fezolinetant | 5/12/2023 | To treat moderate to severe hot flashes caused by menopause Press Release |
15. | Elfabrio | pegunigalsidase alfa-iwxj | 5/9/2023 | To treat confirmed Fabry disease |
14. | Qalsody | tofersen | 4/25/2023 | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation |
13. | Joenja | leniolisib | 3/24/2023 | To treat activated phosphoinositide 3-kinase delta syndrome |
12. | Rezzayo | rezafungin | 3/22/2023 | To treat candidemia and invasive candidiasis |
11. | Zynyz | retifanlimab-dlwr | 3/22/2023 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma |
10. | Daybue | trofinetide | 3/10/2023 | To treat Rett syndrome |
9. | Zavzpret | zavegepant | 3/9/2023 | To treat migraine |
8. | Skyclarys | omaveloxolone | 2/28/2023 | To treat Friedrich’s ataxia |
7. | Filspari | sparsentan | 2/17/2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
6. | Lamzede | velmanase alfa-tycv | 2/16/2023 | To treat non-central nervous system manifestations of alpha-mannosidosis |
5. | Jesduvroq | daprodustat | 2/1/2023 | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months Press Release |
4. | Orserdu | elacestrant | 1/27/2023 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy |
3. | Jaypirca | pirtobrutinib | 1/27/2023 | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor |
2. | Brenzavvy | bexagliflozin | 1/20/2023 | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise |
1. | Leqembi |
lecanemab-irmb |
1/6/2023 | To treat Alzheimer’s disease Press Release |
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