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Perrigo seeks approval for generic bronchospasm drug

BY Alaric DeArment

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

The generic drug maker said it had filed with the Food and Drug Administration for albuterol sulfate HFA inhalation aerosol, a generic version of Teva’s ProAir HFA. Because Perrigo’s approval application contained a legal challenge to Teva’s patent, Teva filed suit against Perrigo and Catalent Pharma Solutions, which also contributed to the application, in the U.S. District Court for the District of Delaware Wednesday, alleging patent infringement.

While Teva’s suit puts a stay on FDA approval of Perrigo’s application, Perrigo likely will be entitled to 180 days of market exclusivity in which to compete directly against the branded product, as long as it wins approval from the agency.

ProAir, used to treat and prevent bronchospasm symptoms in children ages 4 years and older, has sales of about $1.07 billion, according to Wolters Kluwer Health.


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Mylan settles with Pfizer over generic bladder drug

BY Alaric DeArment

PITTSBURGH — Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

The Pittsburgh-based company said it settled with Pfizer over its generic version of Detrol LA (tolterodine tartrate) extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat urge urinary incontinence, urgency and frequency.

Under the terms of the settlement, Mylan can launch its drug starting in 2014, pending final approval by the Food and Drug Administration, either as a generic drug or as an authorized generic, which is a branded drug marketed under its generic name at a reduced price.

The drug had sales of $599 million during the 12-month period ended in June, according to IMS Health.


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CRN to serve as promotional partner for vitamin D scientific symposium

BY Michael Johnsen

WASHINGTON — The Council for Responsible Nutrition on Thursday announced it will serve as a promotional partner for the one-day scientific symposium "Vitamin D: Beyond Bone," presented by the New York Academy of Sciences, The Sackler Institute for Nutrition Science and the Abbott Nutrition Health Institute. 

The keynote speaker will be Daniel Bikle, professor of medicine and dermatology at the University of California, San Francisco, and co-director of the Special Diagnostic and Treatment Unit of the San Francisco VA Medical Center.

The conference will explore recent epidemiological data and the known underlying mechanisms behind vitamin D’s effects on pregnancy, lactation, immune, metabolic, muscle and cardiovascular functions. In addition, the agenda will cover recent changes to vitamin D dietary guidelines and critical next steps in research to help translate data into public health strategies that support the wellbeing of infants, adults and the aging population.

The conference takes place Sept. 21 in New York.


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