Armstrong Pharmaceuticals is advising customers to stockpile its Primatene Mist epinephrine MDI before the FDA ban on CFC formulations takes effect on December 31, 2011. The company says that it is “actively finalizing its internal development” of an HFA formulation but warns that there is likely to be a period of time after the ban goes into effect before the new product is available.
Primatene Mist is available over the counter in the US and has been marketed since 1963. The product costs significantly less than prescription inhalers, with a 15 ml canister (270 doses) costing less than $20. The FDA is referring patients who have been using Primatene Mist and who cannot afford prescription inhalers to payment assistance organizations.
The epinephrine MDI appears to be Armstrong’s only marketed product, although the company web site says that its “pipeline will continue to build upon its substantial experience in the development, manufacture and marketing (mainly in the U.S.) of inhaled respiratory drugs, primarily for bronchial asthma and chronic obstructive pulmonary disease (COPD), delivered by metered-dose inhalers. At the core of Armstrong’s efforts to grow its respiratory business is a continued investment in manufacturing capacity both for metered-dose inhalers and nasal sprays, which allow Armstrong to play an important role in all major markets where it operates.”
Read the Armstrong press release.
