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Statement on Availability of Primatene® Mist CFC

July 26, 2011

CANTON, Mass., July 26, 2011 /PRNewswire/ — Armstrong Pharmaceuticals, Inc. announced the following news today concerning the future availability of Primatene® Mist:

  • On December 31, 2011, the FDA ban on the sale of Primatene® Mist containing CFCs (chlorofluorocarbons) as a propellant will become effective.
  • Primatene® Mist has proven to be a safe and effective treatment for asthma symptoms for over 40 years. The ban on the sale of Primatene® Mist is a result of the Montreal Protocol treaty, which prohibits the sale of certain products containing CFCs. Please see detailed information at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm247196.htm.
  • Armstrong Pharmaceuticals, Inc. is actively finalizing its internal development of a new, CFC-Free Primatene® Mist that will continue to use epinephrine as its active ingredient but will use a more environmentally friendly propellant (known as HFA, or hydrofluoroalkane).
  • There will likely be a period of time between December 31, 2011 and the date of FDA Approval of the new HFA Primatene® Mist product. Please be assured that Armstrong Pharmaceuticals, Inc. is committed to bringing the new product to market in the shortest time possible once the product is approved by the FDA.

Armstrong Pharmaceuticals, Inc. encourages consumers to purchase sufficient Primatene® Mist CFC to bridge the period when the product may not be available for sale.

Please direct all questions regarding Primatene® Mist to our Customer Service Department at 1-8-PRIMATENE (1-877-462-8363).

Armstrong Pharmaceuticals, Inc. is a subsidiary of Amphastar Pharmaceuticals, Inc., a specialty and generic pharmaceutical company. In line with Amphastar’s strong R&D background, Armstrong’s focus is to build upon the substantial experience achieved in the development, manufacture and marketing (mainly in the U.S.) of inhaled respiratory drugs, primarily for bronchial asthma and chronic obstructive pulmonary disease, delivered by Metered Dose Inhalers (MDIs). Amphastar is an American owned and operated company headquartered in Rancho Cucamonga, California. Amphastar, and its subsidiaries, have more than 1,000 employees and have three (3) manufacturing facilities located in Southern California and Canton, Massachusetts. Additional information about Armstrong Pharmaceuticals, Inc. and Amphastar Pharmaceuticals, Inc. can be found at http://www.armstrong-pharma.com and http://www.amphastar.com.

SOURCE Amphastar Pharmaceuticals, Inc.


Source: newswire



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