FDA Review Comments for Daptomycin by Maia Therapeutics

By Rhizome Team

Daptomycin, a cyclic lipopeptide antibiotic approved for treating complicated skin and skin structure infections and Staphylococcus aureus bloodstream infections, continues to be subject to FDA regulatory oversight through post-approval reviews and ongoing safety assessments.

Recent FDA review comments for Daptomycin provide valuable insights into the agency's current focus areas for this important antibiotic, including safety monitoring, manufacturing quality, labeling updates, and post-marketing study requirements. These review comments reflect evolving regulatory expectations and emerging safety data.

Understanding the specific review comments issued by the FDA for Daptomycin helps healthcare professionals, regulatory affairs specialists, and pharmaceutical manufacturers stay informed about the latest regulatory developments and safety considerations for this critical antimicrobial agent.

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what review comments did the FDA have for Daptomycin in the last year?

Answer

From the provided FDA public review documents dated in 2024, FDA’s review comments for daptomycin (Daptomycin for Injection; NDA 217630) included:

  1. Safety / Pharmacovigilance: hyperkalemia signal added to labeling
  • FDA’s Office of Surveillance and Epidemiology (Division of Pharmacovigilance II) evaluated hyperkalemia cases associated with daptomycin using FAERS, published literature, periodic reports, and the applicant’s safety analysis, and found a possible causal association between daptomycin and hyperkalemia; the Division of Anti-Infectives agreed with this assessment. As a result, hyperkalemia was added to the product labeling under Adverse Reactions (Postmarketing Experience). 65
  • The Pharmacovigilance Review for this topic is dated August 23, 2024 and is explicitly “Subject: Hyperkalemia.” 1
  1. Labeling (Prescribing Information) review: specific changes and acceptability determinations
  • FDA compared the finalized Prescribing Information to the applicant’s draft submitted January 22, 2024 and made/confirmed changes to ensure the PI met regulatory requirements and was clear and scientifically accurate for safe use. 6
  • Example of an FDA acceptability comment: the applicant added Lactated Ringer’s Injection as a compatible diluent for reconstituted product; FDA stated “This is acceptable. No changes.” 6
  1. Medication error prevention (DMEPA) labeling review: safety-related improvement comments (details redacted)
  • FDA’s Division of Medication Error Prevention and Analysis (DMEPA) reviewed the proposed Prescribing Information, container labels, and carton labeling for vulnerabilities that could lead to medication errors. 11
  • FDA concluded that the proposed PI/container/carton labeling “may be improved to promote safe use… from a medication error perspective,” and indicated it provided identified medication error issues and recommendations to minimize risk (however, the detailed issues/recommendations are not included in the public snippet and the document is marked as containing proprietary information). 1112
  1. Chemistry/Manufacturing/Controls (OPQ) review: quality found acceptable; approval recommended
  • FDA’s Office of Pharmaceutical Quality (OPQ) stated it recommends approval of NDA 217630 from a product quality perspective, noting the applicant provided sufficient information to support approval. 8
  • OPQ also found key quality elements acceptable, including 24-month expiration dating at 20–25°C. 8
  • OPQ noted that, after internal discussions with DMEPA and clinical review teams, the applicant was asked to remove certain (redacted) content to prevent medication errors during administration. 26
  1. Regulatory outcome context (within the same review cycle)
  • The NDA was filed April 2, 2024 with a PDUFA goal date of November 22, 2024. 4
  • The approval package indicates FDA approval occurred on November 21, 2024 for Daptomycin for Injection (NDA 217630). 14

Limitations based on provided sources:

  • Some FDA medication error review content is explicitly labeled proprietary and/or redacted, so only the high-level conclusion that labeling “may be improved” and that recommendations were provided can be stated from these snippets. 1112