FDA Novel Drug Approvals
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The U.S. Food & Drug Administration recently approved the following drug therapies:
Dermatology
- Seysara, with active ingredient sarecycline, to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Immunology
- Revcovi, with active ingredient elapegademase-lvlr, to treat Adenosine Deaminase-Severe Combined Immunodeficiency.
Internal Medicine/Primary Care
- Xofluza, with active ingredient baloxavir marboxil, to treat acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours.
Molecular biology
- Tegsedi, with active ingredient inotersen, to treat polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Neurology
- Emgality, with active ingredient galcanezumab-gnlm, for the preventive treatment of migraine in adults.
- Ajovy, with active ingredient fremanezumab-vfrm, for the preventive treatment of migraine in adults.
Oncology/Hematology
- Libtayo, with active ingredient cemiplimab-rwlc, to treat cutaneous squamous cell carcinoma (CSCC).
- Vizimpro, with active ingredient dacomitinib, to treat metastatic non-small-cell lung cancer.
- Copiktra, with active ingredient duvelisib, to treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma.
- Lumoxiti, with active ingredient moxetumomab pasudotox-tdfk, to treat hairy cell leukemia.
- Lorbrena, with active ingredient loratinib, to treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer.
- Talzenna, with active ingredient talazoparib, to treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
Pulmonology
- Nuzyra, with active ingredient omadacycline, to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
- Yupelri, with active ingredient revefenacin, to treat patients with chronic obstructive pulmonary disease.
For more information
Visit the FDA’s website.
