Perrigo Co. (PRGO) Files ANDA for Generic ProAir HFA
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Perrigo Company (Nasdaq: PRGO) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for albuterol sulfate HFA inhalation aerosol, the generic version of ProAir HFA. The ANDA filing involved contributions from both Perrigo and Catalent Pharma Solutions, Inc., who partnered on the development of this project.
Perrigo previously notified Teva Branded Pharmaceutical Products R&D, Inc., the owner of the New Drug Application, and others, of its ANDA filing that challenged the patents listed in FDA's Orange Book. On September 5, 2012, Teva filed suit against Perrigo and Catalent in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
ProAir® HFA (albuterol sulfate) Inhalation Aerosol is a prescription medicine indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm symptoms. Annual sales were approximately $1.07 Billion annually, as measured by Wolters Kluwer Health.
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Perrigo previously notified Teva Branded Pharmaceutical Products R&D, Inc., the owner of the New Drug Application, and others, of its ANDA filing that challenged the patents listed in FDA's Orange Book. On September 5, 2012, Teva filed suit against Perrigo and Catalent in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
ProAir® HFA (albuterol sulfate) Inhalation Aerosol is a prescription medicine indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm symptoms. Annual sales were approximately $1.07 Billion annually, as measured by Wolters Kluwer Health.
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