(AGENPARL) - Roma, 21 Giugno 2022

(AGENPARL) – SILVER SPRING mar 21 giugno 2022

No. Drug
Name Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)
Press Release
Drug Trials Snapshot 58. Elzonris tagraxofusp-erzs 12/21/2018 To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Press Release
Drug Trials Snapshot 57. 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 56. Motegrity prucalopride 12/14/2018 To treat chronic idiopathic constipation
Drug Trials Snapshot 55. Xospata gilteritinib 11/28/2018 To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
Press Release
Drug Trials Snapshot 54. Firdapse amifampridine 11/28/2028 To treat  Lambert-Eaton myasthenic syndrome (LEMS) in adults
Press Release
Drug Trials Snapshot 53. Vitrakvi larotrectinib 11/26/2018 To treat patients whose cancers have a specific genetic feature (biomarker)
Press Release
Drug Trials Snapshot 52. Daurismo glasdegib 11/21/2018 To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients
Press Release 
Drug Trials Snapshot 51. Gamifant emapalumab-lzsgemapalumab-lzsg 11/20/2018 To treat primary hemophagocytic lymphohistiocytosis (HLH)
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Drug Trials Snapshot 50. Aemcolo rifamycin 11/16/2018 To treat travelers’ diarrhea
Press Release
Drug Trials Snapshot 49. Yupelri revefenacin 11/9/2018 To treat patients with chronic obstructive pulmonary disease (COPD)
Drug Trials Snapshot 48. Lorbrena lorlatinib 11/2/2018 To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Drug Trials Snapshot 47. Xofluza baloxavir marboxil 10/24/2018 To treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
Press Release
Drug Trials Snapshot 46. Talzenna talazoparib 10/16/2018 To treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
Drug Trials Snapshot 45. Tegsedi inotersen 10/5/2018 To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Drug Trials Snapshot 44. Revcovi elapegademase-lvlr 10/5/2018 To treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID)
Drug Trials Snapshot 43. Nuzyra omadacycline 10/2/2018 To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
Drug Trials Snapshot for community-acquired bacterial pneumonia 42. 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 41. Libtayo cemiplimab-rwlc 9/28/2018 To treat cutaneous squamous cell carcinoma (CSCC)
Drug Trial Snapshot 40. Vizimpro dacomitinib 9/27/2018 To treat metastatic non-small-cell lung cancer
Drug Trials Snapshot 39. Emgality galcanezumab-gnlm 9/27/2018 For the preventive treatment of migraine in adults
Drug Trials Snapshot 38. Copiktra duvelisib 9/24/2018 To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma
Drug Trials Snapshot 37. Ajovy fremanezumab-vfrm 9/14/2018 For the preventive treatment of migraine in adults
Drug Trials Snapshot 36. Lumoxiti moxetumomab pasudotox-tdfk 9/13/2018 To treat hairy cell leukemia
Press Release
Drug Trials Snapshot 35. Pifeltro doravirine 8/30/2018 To treat HIV-1 infection in adult patients
Drug Trials Snapshot 34. Xerava eravacycline 8/27/2018 To treat complicated intra-abdominal infections in patients 18 years of age and older
Drug Trials Snapshot 33. Takhzyro lanadelumab 8/23/2018 To treat types I and II hereditary angioedema
Drug Trials Snapshot 32. Oxervate cenegermin-bkbj 8/22/2018 To treat neurotrophic keratitis
Press Release
Drug Trials Snapshot 31. 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 30. Galafold migalastat 8/10/2018 To treat treat adults with Fabry disease.
Press Release
Drug Trials Snapshot 29. 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 28. Onpattro patisiran 8/10/2018 To treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adult patients
Press Release
Drug Trials Snapshot 27. Poteligeo mogamulizumab-kpkc 8/8/2018 To treat two rare types of non-Hodgkin lymphoma
Press Release
Drug Trials Snapshot 26. 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 25. 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 24. Orilissa elagolix sodium 7/23/2018 For the management of moderate to severe pain associated with endometriosis
Drug Trials Snapshot 23. Krintafel tafenoquine 7/20/2018 For the radical cure (prevention of relapse) of Plasmodium vivax malaria
Drug Trials Snapshot 22. Tibsovo ivosidenib 7/20/2018 To treat patients with relapsed or refractory acute myeloid leukemia
Press Release
Drug Trials Snapshot 21. TPOXX tecovirimat 7/13/2018 To treat smallpox
Press Release
Drug Trials Snapshot 20. Braftovi encorafenib 6/27/2018 To treat unresectable or metastatic melanoma
Drug Trials Snapshot 19. Mektovi binimetinib 6/27/2018 To treat unresectable or metastatic melanoma
Drug Trials Snapshot 18. Zemdri plazomicin 6/25/2018 To treat adults with complicated urinary tract infections
Drug Trials Snapshot 17. Epidioloex cannabidiol 6/25/2018 To treat rare, severe forms of epilepsy
Press Release
Drug Trials Snapshot 16. Moxidectin moxidectin 6/13/2018 To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
Drug Trials Snapshot 15. Olumiant baricitinib 5/31/2018 To treat moderately to severely active rheumatoid arthritis
Drug Trials Snapshot 14. 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 13. 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 12. Lokelma sodium zirconium cyclosilicate 5/18/2018 To treat hyperkalemia
Drug Trials Snapshot 11. Aimovig erenumab-aooe 5/17/2018 For the preventive treatment for migraine
Press Release
Drug Trials Snapshot 10. Lucemyra lofexidine hydrochloride 5/16/2018 For the non-opioid treatment for management of opioid withdrawal symptoms in adults
Press Release
Drug Trials Snapshot 9. 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 8. Crysvita burosumab-twza 4/17/2018 To treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets
Press Release
Drug Trials Snapshot 7. Tavalisse fostamatinib 4/17/2018 To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
Drug Trials Snapshot 6. 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 5. Trogarzo ibalizumab-uiyk 3/6/2018 To treat HIV patients who have limited treatment options
Press Release
Drug Trials Snapshot 4. Erleada apalutamide 2/14/2018 To treat a certain type of prostate cancer using novel clinical trial endpoint
Press Release
Drug Trials Snapshot 3. Symdeko tezacaftor; ivacaftor 2/12/2018 To treat cystic fibrosis in patients age 12 years and older
Drug Trials Snapshot 2. 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 1. Lutathera lutetium Lu 177 dotatate 1/26/2018 To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Press Release
Drug Trials Snapshot

Fonte/Source: http://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019