U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Drug and Biologic Approval and IND Activity Reports
  6. NDA and BLA Approvals
  7. Accelerated Approval Program
  8. Ongoing | Infectious Disease Accelerated Approvals (excluding vaccines)
  1. Accelerated Approval Program

Ongoing | Infectious Disease Accelerated Approvals (excluding vaccines)

This listing includes accelerated approvals (AAs) for infectious disease indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements. 

Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.

Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status. 

Ongoing 1 Infectious Diseases Accelerated Approvals

Total approval time was adjusted based on management decision. This is a legacy practice and is no longer exercised.

Drug Name Accelerated Approval Indication Accelerated Approval Date AA PMR Original Projected Completion Date 2
Benznidazole For the treatment of Chagas disease (American trypanosomiasis), caused by trypanosoma cruzi, in pediatric patients 2 to 12 years of age 8/29/2017 PMR 3247-1: Conduct a prospective, single-arm, multicenter trial, with historical controls, to evaluate safety, efficacy and pharmacokinetics of benznidazole tablets for treatment of Chagas disease in children. 5/31/2026
Arikayce (amikacin liposome inhalation suspension) For the treatment of mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. Clinical benefit has not yet been established 9/28/2018 PMR 3480-1: Conduct a randomized, double-blind, placebo-controlled clinical trial to assess and describe the clinical benefit of ARIKAYCE in patients with nontuberculous mycobacterial (NTM) lung disease caused by MAC. The trial will evaluate the effect of ARIKAYCE on a clinically meaningful endpoint, as compared to an appropriate control in the intended patient population of patients with MAC infection. 6/30/2024

 

 

  • 1"Ongoing" refers to accelerated approval (AA) applications that have not yet converted to full approval, and not to the status of the AA postmarketing requirement (PMR).
  • 2If multiple PMRs were required, the latest date is reported here. This date represents the original agreed-upon Final Study Report date and does not include any updated deadlines submitted by the Applicant.
Back to Top