Sen. Brown to assess FDA ‘fast track’ designation
WASHINGTON Sen. Sherrod Brown, D-Ohio, has asked Congress for information on the Fast Track designation to help determine whether the program should be changed or eliminated completely, according to published reports. Fast Track was intended to speed up the availability of drugs for serious diseases.
Brown discovered that the designation has done little to benefit consumers and is more of a benefit to investors, who use it as a way to make quick money in the stock market.
Brown said the research will cover the various FDA programs to develop and review drugs and will help provide an assessment of Fast Track’s impact in preparation for discussions with Senate colleague Edward Kennedy, a Massachusetts Democrat. Congress approved the Fast Track designation in 1997 as part of extensive legislation to streamline the system for approving drugs and medical devices.
Kennedy tried to support the designation by stating, “Fast Track designation is meant to speed the review of urgently needed medicines, and it should not be abused to artificially inflate a company’s profits. Congress should see that the Fast Track process is not abused and retains its intended purpose of seeing that important new medicines reach the patients who need them without undue delay.”
A top FDA official acknowledged that Fast Track gives drug companies access to the same programs that were in place before the designation and provides no unique benefits to speed the development and approval of drugs.
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.