MAY 2023

by Editorial Board last updated Apr 09, 2024 02:28 PM

SARS-CoV-2 / COVID-19

US FDA Drug Approvals

  • A co-packaged product containing nirmatrelvir and ritonavir tablets (Paxlovid) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Drug manufactured and packaged under the EUA and distributed by DHHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. See FDA news release here.
  • A co-packaged product containing injectable sulbactam and durlobactam (Xacduro), for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients ≥18 years of age. Sulbactam is a beta-lactamase inhibitor with intrinisic activity against Acinetobacter baumannii; durlobactam is a beta-lactamase inhibitor which helps to prevent degradation of sulbactam by enzymes produced by A. baumannii. Recommended dosage in normal renal function is 1 gm of sulbactam and 1 gm of durlobactam IV q6h (infused over three hours). The co-packaged product was granted Priority Review and designated as a Qualified Infectious Disease Product (QIDP). Availability is expected later this year. See FDA news release here.

COVID Vaccine Summary

  • Latest recommendations from CDC (April 19, 2023 - normal host)(May 1, 2023 - immunocompromised) are that monovalent (original) mRNA vaccines are no longer recommended in the US.
  • Almost the entire US population has antibody against SARS-CoV-2 (via previous infection or vaccination).
  • All persons >6 years of age who are unvaccinated or previously completed a monovalent primary series should receive a bivalent mRNA vaccine. No further doses are needed except persons who are >65 years of age or immunocompromised.
  • A single additional bivalent vaccine dose for adults 65 years, and one or more additional doses for people who are immunocompromised, are recommended.
  • Immunocompromised persons age >12 years have the option to receive one additional dose of the Moderna (0.5 mL/50 µg) or Pfizer (0.3 mL/30 µg) vaccine ≥2 months following the last recommended bivalent dose. Further additional dose(s) may be administered, informed by clinical judgment and personal preference and circumstances ≥2 months after the last vaccine dose.
  • For young children, multiple doses continue to be recommended and vary by age, vaccine, and which vaccines were previously received. See Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine.

RSV Vaccine Approved

  • The US FDA has approved a respiratory syncytial virus (RSV) adjuvanted vaccine (Arexvy) for use in individuals 60 years of age and older. Dosage is a single 0.5 mL IM injection. The vaccine will not be released until fall. See FDA news release here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 5, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since April 8, 2023:
      • None
    • Shortage recently resolved:
      • Rifampin injection
      • Rifapentine 150 mg tablets
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin injection
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection
        • Penicillin G benzathine/Penicillin G procaine (Bicillin)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Rifaximin 200 mg tablets
      • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs
      • Isoniazid 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)