FDA approves Nycomed’s Alvesco
WASHINGTON The Food and Drug Administration has approved Nycomed’s new drug Alvesco, which is an inhalation aerosol used for the maintenance of asthma and as a prophylactic therapy in adult and adolescent patients aged 12 years and older.
“The approval of Alvesco provides a new and effective treatment option to help patients control their asthma and improve their quality of life, and will be an important treatment option for physicians,” said Myron Zitt, chief of allergy and immunology at the Queens Long Island Medical Group in Babylon, N.Y., and clinical associate professor of medicine at the State University of New York, Stony Brook, School of Medicine.
The drug has been given patent protection until 2017 by the FDA. Nycomed is still looking for marketing and commercializing partnerships for the drug in the U.S.
Taro settles patent suit, launches generic Trileptal
HAWTHORNE Taro announced Wednesday that it has settled a patent lawsuit with Novartis and will launch oxcarbazepine tablets, the generic version of Novartis’ Trileptal. Oxcarbazepine tablets are indicated to treat seizures.
The litigation with Novartis centered on Taro’s Paragraph IV certification challenging Novartis’ patent protection on Trileptal. On Nov. 15, 2007, Taro received Food and Drug Administration approval for its abbreviated new drug application for oxcarbazepine tablets in 150 mg, 300 mg and 600 mg strengths, but the company waited to launch the drug until the lawsuit was settled.
According to Taro, Trileptal currently has annual U.S. sales of approximately $700 million.
Sciele to launch six medications in 2008
ATLANTA In addition to Sciele’s announcement last week, reported in Drug Store News, that it will launch its new Sular formulation during the first quarter of 2008, the company also announced plans to launch five other drugs this year:
- two new dosages of fenofibrate for the treatment of mixed dyslipidemia
- Prandin for Type 2 diabetes
- PrandiMet for Type 2 diabetes (pending FDA approval)
- a head lice asphyxiation product (pending FDA approval)
- a women’s health product
Sciele reaffirmed its full-year guidance at the JPMorgan 26th Annual Health Care Conference yesterday. As previously announced, full-year 2007 revenue is expected to range between $375 million and $385 million. The company expects full-year 2008 revenues to range from $440 million to $455 million.