Clinical Guideline Alerts (SEPT 22)

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FDA Drug Approvals (SEPT 22)
  • Spevigo (Boehringer Ingelheim)
    • For the treatment of flares in adults with generalized pustular psoriasis (GPP).
  • Imfinzi (AstraZeneca)
    • In combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC).
  • Konvomep (Azurity Pharmaceuticals)
    • For the treatment of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill patients.
  • Stimufend (Fresenius Kabi)
    • For use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Daxxify (Revance Therapeutics)
    • For the temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.
  • Sotyktu (Bristol Myers Squibb)
    • For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
  • Rolvedon (Spectrum Pharmaceuticals)
    • To decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
  • Terlivaz (Mallinckrodt)
    • To improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function.
  • Skysona (Bluebird Bio)
    • To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).
  • Aponvie (Heron Therapeutics)
    • For the Prevention of Postoperative Nausea and Vomiting (PONV).
  • Pedmark (Fennec Pharmaceuticals)
    • To reduce the risk for ototoxicity associated with cisplatin in pediatric patients 1 month of age or older with localized, nonmetastatic solid tumors.
  • Retevmo (Eli Lilly)
    • For adults with locally advanced or metastatic RET fusion-positive solid tumors that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.
  • Elucirem (Guerbet)
    • For contrast-enhanced MRIs.
  • Omlonti (Santen Pharmaceuticals / UBE Corp.)
    • For the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension.
  • Iheezo (Harrow)
    • For ocular surface anesthesia.
  • Dupixent (Sanofi / Regeneron)
    • For the treatment of adult patients with prurigo nodularis.
  • Relyvrio (Amylyx Pharmaceuticals)
    • For the treatment of adults with amyotrophic lateral sclerosis (ALS).
  • Firdapse (Catalyst Pharmaceuticals)
    • To include pediatric patients, six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”).
  • Lytgobi (Taiho Oncology)
    • For the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
  • Vegzelma (Celltrion Healthcare)
    • Multiple indications similar to Avastin.

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