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Amphastar Pharmaceuticals Inc.

www.amphastar.com

Latest From Amphastar Pharmaceuticals Inc.

OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

Approvals Drug Approval Standards

OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

Approvals Drug Approval Standards

Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.
Respiratory Drug Approval Standards

Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.
Respiratory Drug Approval Standards
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Nasal
      • Pulmonary
    • Generic Drugs
    • OTC, Consumer
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Amphastar Pharmaceuticals Inc.
  • Senior Management
  • Jack Y Zhang, PhD, CEO, CSO
    Bill Peters, CFO, Treasurer
    Mary Z Luo, PhD, COO, Chief Scientist
    Jason B Shandell, JD, MBA, President
  • Contact Info
  • Amphastar Pharmaceuticals Inc.
    Phone: (800) 423-4136
    11570 6th St.
    Rancho Cucamonga, CA 91730
    USA
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