FDA gives tentative approval to Barr’s generic Mirapex
WASHINGTON Barr Laboratories has received tentative approval from the Food and Drug Administration for its generic version of Boehringer Ingelheim Pharmaceuticals’ Mirapex, a drug used for the signs and symptoms of Parkinson’s disease.
Barr filed its abbreviated new drug application for generic Mirapex (pramipexole) 0.25 mg in May 2005. A month later, the company changed the application to include the tablet strengths 0.125, 0.5, 1 and 1.5 mg.
Boehringer Ingelheim filed suit in the U.S. District Court in Delaware Sept. 26, 2005, to prevent Barr from proceeding with commercialization of the product.
Although a trial has been scheduled for Nov. 5, due to a judicial vacancy in the court, the trial is not expected to begin on schedule. A new trial date has not been set.
Sandoz completes $10 million expansion of N.C. facility
WILSON, N.C. Sandoz recently completed the major phase of its Wilson, North Carolina expansion when over 50 employees moved into a new 30,000 square foot building.
Over 65 new jobs are expected to be created in Wilson as a result of the $10 million expansion. The positions will be filled by pharmaceutical scientists and analytical chemists and will bring the total of employees at the site to almost 480.
“The new laboratories present an excellent workplace and opportunity for top scientists to help us continue to growth in the U.S.,” said Bernhard Hampl, president and chief executive officer of Sandoz. “The new products developed at the site will be the basis for the future growth of the Wilson site.”
Pfizer, Taisho sign letter of intent over schizophrenia drug candidate
TOKYO and NEW YORK Taisho Pharmaceuticals and Pfizer have concluded on a letter of intent with regard to Taisho’s new drug candidate for schizophrenia, TS-032.
The drug is currently in the pre-clinical stage and the letter of intent relates to a proposed license agreement regarding rights for development and commercialization.
Through the agreement, Taisho will grant exclusive development and commercialization rights outside Japan for the drug to Pfizer. Once the agreement is signed, Taisho will receive an initial payment of $22 million as well as milestone and royalties linked to the development and sales of the drug.