NDAINTRAVENOUSSOLUTION
Approved
Jun 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZIPRES is an intravenous ephedrine hydrochloride solution approved by the FDA in June 2021 for management of hypotension. Ephedrine is a sympathomimetic amine that stimulates alpha and beta-adrenergic receptors to increase blood pressure and heart rate. It is typically used in acute care settings such as operating rooms, intensive care units, and emergency departments.
Peak
Product is in peak commercial phase with moderate competitive pressure (30%); team expansion likely focused on maintaining market position in acute care channels.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Started Jan 2015
53 enrolled
Common Cold
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
Started Dec 2014
80 enrolled
Healthy
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Started Apr 2014
66 enrolled
Pain, HeadPain, AcutePain, Back+1 more
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fasting Conditions
Started Jul 2005
40 enrolled
Allergies
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions
Started Jun 2005
40 enrolled
Allergies
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.