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Amphastar Pharmaceuticals (AMPH)
NASDAQ:AMPH
I004, Novolog
Pharmacokinetics, Pharmacodynamics
Phase II/III
Completed
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers
Sep 12, 2022
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Epinephrine (0.125 Mg/Inhalation), Epinephrine Injection Auto-Injector (0.3Mg/0.3Ml), Albuterol Sulfate (0.09 Mg/Inhalation)
Asthma, Pharmacokinetics, Epinephrine, Albuterol, Anaphylaxis
Phase IV
Completed
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
Dec 19, 2019
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A006 Dpi, Proventil® Mdi
Asthma
Phase II
Completed
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
Oct 20, 2014
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A006 Dpi, Proventil® Mdi
Asthma
Phase II
Completed
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
Aug 04, 2014
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Epinephrine Hfa-Mdi (E004)
Asthma
Phase III
Completed
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
Nov 20, 2012
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Arm T Epinephrine Inhalation Aerosol Hfa, 125 Mcg, 1 Inhalation, Arm C-Epinephrine Inhalation Aerosol Cfc
Asthma
Phase I/II
Terminated
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
Nov 20, 2012
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Saline, Hyaluronidase, Histamine
Allergic Skin Reaction
Phase II
Completed
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Sep 13, 2012
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Albuterol Dpi 25 Mcg/Inh, Albuterol Dpi 90 Mcg/Inh, Albuterol Mdi 90 Mcg/Inh
Asthma
Phase II
Completed
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
Apr 17, 2012
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Primatene Mist, Epinephrine Inhalation
Asthma
Phase III
Completed
Safety Study in Adolescent and Adult Patients With Asthma
Nov 15, 2011
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E004 (Epinephrine Inhalation Aerosol) Hfa-Mdi
Asthma
Phase III
Completed
Evaluation of Efficacy and Safety of E004 in Children With Asthma
Oct 24, 2011
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Amphastar Pharmaceuticals (AMPH) have in its pipeline
AMPH is currently developing the following drugs: I004, Novolog, Epinephrine (0.125 Mg/Inhalation), Epinephrine Injection Auto-Injector (0.3Mg/0.3Ml), Albuterol Sulfate (0.09 Mg/Inhalation), A006 Dpi, Proventil® Mdi. These drug candidates are in various stages of clinical development as the company works toward FDA approval.