April 2023: Notable Drug Approvals


Pharmacologic Class


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Dermatologic Disorders
Brella 3-Minute Sweat Control Patch Single-use disposable patch consists of a sodium sheet Treatment of primary axillary hyperhidrosis. FDA Clears Patch Therapy to Reduce Excessive Underarm Sweating in Adults
Endocrine Disorders
Sogroya (somapacitan-beco) Human growth hormone analog Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone. Once-Weekly Sogroya Approved for Pediatric Growth Hormone Deficiency
Padcev (enfortumab vedotin-ejfv) + Keytrude (pembrolizumab) Nectin-4 directed antibody-drug conjugate and programmed death receptor-1 blocking antibody First-line treatment of adults with locally advanced or metastatic urothelial cancer who are ineligible to receive cisplatin-containing chemotherapy. Padcev Plus Keytruda Approved as First-Line Treatment for Urothelial Cancer
Polivy (polatuzumab vedotin-piiq)
CD79b-directed antibody and microtubule inhibitor conjugate.
In combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater. Polivy Combination Therapy Approved for Previously Untreated DLBCL
Omisirge (omidubicel-onlv) Nicotinamide modified allogeneic hematopoietic progenitor cell therapy Treatment of patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. FDA Approves Omisirge, an Allogeneic Cell Therapy for Patients With Blood Cancers
Prevnar 20 (20-valent pneumococcal conjugate vaccine)
Capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F
The prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae serotypes in infants and children 6 through 17 years of age, and for the prevention of otitis media caused by 7 of the 20 Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in infants and children 6 weeks through 5 years of age. FDA Approves Prevnar 20 Vaccine for Use in Infants and Children
Infectious Disease
Vowst (fecal microbiota spores, live-brpk) Purified bacterial spores of multiple Firmicute species To prevent the recurrence of C. difficile (CDI) infection in adults 18 years of age and older following antibacterial treatment for recurrent CDI. Vowst Approved to Prevent Recurrent C. difficile Infection
Neurologic Disorders
Qalsody (tofersen) Antisense oligonucleotide Treatment of adults with amyotrophic lateral sclerosis who have a mutation in the superoxide dismutase 1 gene. Qalsody Approved for SOD1 Amyotrophic Lateral Sclerosis
Pain Management
Qulipta (atogepant) Calcitonin gene-related peptide receptor antagonist Preventive treatment of chronic migraine in adults. Qulipta Approval Expanded to Include Preventive Treatment of Chronic Migraine
Psychiatric Disorders
Abilify Asimtufii (aripiprazole extended-release injectable suspension) Atypical antipsychotic Treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults. Abilify Asimtufii Approved for Schizophrenia, Bipolar I Disorder
Uzedy (risperidone) Atypical antipsychotic Treatment of schizophrenia in adults. Uzedy, Long-Acting Schizophrenia Treatment, Gets FDA Approval