GSK’s Traber to lead FDA approval process for Pro-Pharmaceuticals drug
NEWTON, Mass. The acting chief medical officer for GlaxoSmithKline will lead a phase 3 trial for an investigational colorectal cancer treatment on behalf of Pro-Pharmaceuticals.
Peter Traber will lead the trial for Davanat, as well as the overall Food and Drug Administration approval process. Traber has served on Pro-Pharmaceuticals’ board of directors since 2009, the drug maker said.
“Dr. Traber has a unique combination of medical, clinical drug development, management and regulatory experience,” said James Czirr, executive chairman for Pro-Pharmaceuticals. “We believe leveraging Dr. Traber’s extensive experience and success in designing and managing clinical trials will contribute significantly to our goal of commercializing Davanat.”
Intellipharmaceutics files new drug application for generic Protonix
TORONTO Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat gastrointestinal issues, the drug maker said.
Intellipharmaceutics said its pantoprazole sodium delayed-release tablets — a generic version of Protonix — inhibits gastric acid secretion and is prescribed for the short-term treatment of such conditions as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009.
“I am extremely pleased with the progress we continue to make with the advancement of our product pipeline,” said Isa Odidi, Intellipharmaceutics CEO. “Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our company’s ANDA pipeline.”
Injunction blocks Dr. Reddy’s generic Allegra D24
NEW YORK A U.S. District Court has granted French drug maker Sanofi-Aventis and Albany Molecular Research an injunction halting the launch of a generic version of one of its drugs made by Dr. Reddy’s Labs, Dr. Reddy’s said.
The U.S. District Court for the District of New Jersey blocked the release of Dr. Reddy’s fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets in the 180 mg and 240-mg strength, a generic version of Allegra D24, marketed by Sanofi-Aventis and discovered by Albany Molecular Research.
Dr. Reddy’s said it strongly disagreed with the lawsuit and intended to appeal. According to published reports, the Food and Drug Administration had approved Dr. Reddy’s version of the drug following a 30-month stay of approval resulting from a patent infringement lawsuit filed against the company when it tried to seek approval for the generic. The last patents covering Allegra D24 expire in December 2020.