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Armstrong Pharmaceuticals Inc.

Division of Amphastar Pharmaceuticals Inc.
http://www.armstrong-pharma.com

Latest From Armstrong Pharmaceuticals Inc.

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

Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

Consumer Drug Safety

Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

Consumer Drug Safety
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Amphastar Pharmaceuticals Inc.
  • Senior Management
  • Contact Info
  • Armstrong Pharmaceuticals Inc.
    Phone: (617) 323-7404
    423 LaGrange St
    West Roxbury, MA 02132
    USA
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