Anesthesia · Opioid
The FDA's grant of Abbreviated New Drug Application (ANDA) approval status for Sufentanil Citrate by Hospira is significant as it positions the company to compete more effectively in the anesthesia market. Strategic teams should evaluate the implications for market dynamics and pricing strategies as this product approaches market entry.
Multi-agent research across ingested FDA, EMA, MHRA, PMDA, PubMed, ClinicalTrials.gov, company documents, and Humanexa signals.
Last run 7/8/2026, 6:04:41 AM
Assessment confidence: 53% · The main uncertainty is whether clinical benefit translates into regulatory momentum and guideline influence.
The FDA's grant of Abbreviated New Drug Application (ANDA) approval status for Sufentanil Citrate by Hospira is significant as it positions the company to compete more effectively in the anesthesia market. Strategic teams should evaluate the implications for market dynamics and pricing strategies as this product approaches market entry. Regulatory context from FDA (FDA AP — SUFENTANIL CITRATE (SUPPL)) supports the near-term read. Assessment grounded in 13 ranked evidence items (4 high-relevance).
Strategic teams should assess the potential market impact and pricing strategies for Sufentanil Citrate in light of this approval. The strongest clinical anchor is The Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery (ClinicalTrials.gov), sub-indication match (pain). In pain, 8 regulatory and 0 competitive items passed relevance filtering for Hospira.
The most relevant competitive pressure comes from This approval status may enhance Hospira's competitive position in the anesthesia market, particularly against branded products..
Regulatory risk is concentrated around FDA AP — SUFENTANIL CITRATE (SUPPL) (FDA). Entity match (hospira); Regulatory pathway relevance (nda). While the ANDA approval status is a positive step, the final approval and subsequent market entry will need to be closely monitored to assess compliance and market readiness.
FDA AP — SUFENTANIL CITRATE (SUPPL)
FDAmedium relevance
Entity match (hospira); Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceFDA AP — TOFACITINIB CITRATE (ORIG)
FDAmedium relevance
Regulatory pathway relevance (nda)
FDA document
View sourceThe Effect of Superficial Cervical Block Application on Postoperative Opioid Consumption in Patients Undergoing Anterior Cervical Discectomy Surgery
ClinicalTrials.govhigh relevance
Sub-indication match (pain)
FDA document
View sourceOpioid Rapid Response System: Naloxone Training in Communities
ClinicalTrials.govhigh relevance
Sub-indication match (pain)
FDA document
View sourceMirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment
ClinicalTrials.govhigh relevance
Sub-indication match (pain)
FDA document
View sourceOndexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
ClinicalTrials.govmedium relevance
Sponsor/company relevance (AstraZeneca)
FDA document
View sourceVertiGreens Investigating the Effects of Iron Biofortification of Microgreens on Iron Status in Women
ClinicalTrials.govlow relevance
Weak alignment to signal sub-indication and entities
FDA document
View sourceShaping Community-based Pathway to Improve TB Surveillance Among African and Hindustan Immigrants Experiencing Vulnerabilities
ClinicalTrials.govlow relevance
Weak alignment to signal sub-indication and entities
FDA document
View sourceRemote Dynamic Cycling for the Customized Off-site Rehab in Parkinson's Disease
ClinicalTrials.govlow relevance
Weak alignment to signal sub-indication and entities
FDA document
View sourceFDA Grants Emergency Use Authorization for Remdesivir in Severe COVID-19 Cases
Humanexa Signalslow relevance
Weak alignment to signal sub-indication and entities
Impact of oliceridine versus sufentanil on postoperative nausea and vomiting in patients undergoing thyroid surgery: a prospective, double-blind, randomized controlled trial.
PubMedhigh relevance
Sub-indication match (pain)
FDA document
View sourceEffects of acute HMB-FA supplementation on antioxidant status and muscle damage in Elite Judoka: a randomized pilot trial.
PubMedlow relevance
Weak alignment to signal sub-indication and entities
FDA document
View sourcePrecedents · guidance
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View full competitive analysisThe FDA's grant of Abbreviated New Drug Application (ANDA) approval status for Sufentanil Citrate by Hospira is significant as it positions the company to compete more effectively in the anesthesia market. Strategic teams should evaluate the implications for market dynamics and pricing strategies as this product approaches market entry.
The approval could lead to increased market share for Hospira in the anesthesia segment, potentially impacting revenue from both branded and generic competitors.
While the ANDA approval status is a positive step, the final approval and subsequent market entry will need to be closely monitored to assess compliance and market readiness.
Monitor for the final approval and market entry timeline for Sufentanil Citrate.
Track for follow-up milestones; no immediate action required.