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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.
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.
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.
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.
Company Information
- Industry
- Pharmaceuticals
- Therapeutic Areas
- Non-Specific
- Alias(es)
- Ownership
- Private
- Headquarters
-
Worldwide
-
North America
-
USA
-
USA
-
North America
- 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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