FDAnews Drug Daily Bulletin

Patent settlements that involve a branded company’s commitment to not launch an authorized generic (AG) in competition with a generic company (no-AG agreements) are “without a doubt” anticompetitive pay-for-delay deals even though no cash payments are involved, the FTC says in an amicus brief.

Dialysis-drug maker Fresenius has been handed a Form 483 after an FDA inspection of its Ogden, Utah, facility raised concerns that post-sterilization visual inspections performed on solution bags may not be effective at catching leaks or contaminants.

Generic drugs have saved the U.S. more than $1 trillion over the past decade, a figure that well exceeds predictions from when the Hatch-Waxman Act was enacted in 1984, according to a new study.

Pfizer has agreed to acquire rights to market AstraZeneca’s popular heartburn drug Nexium for OTC use, paying $250 million up front as well as milestone and royalty payments.

The Food and Drug Administration says it has approved the new flu vaccine for the season beginning this year.

Acorda Therapeutics has reported negative top line results from post-marketing commitment study exploring 5mg dose of Dalfampridine-ER in multiple sclerosis (MS) patients.

Santarus said that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the NDA for UCERIS (budesonide) tablets 9 mg for the induction of remission for  mild to moderate active ulcerative colitis from Oct. 16, 2012, to Jan. 16, 2013.

Nymox Pharmaceutical reported a second quarter net loss of $1.7 million, or 5 cents a share, as its lead product advances into late-stage development.

Investor Carl Icahn expressed concerns about Forest Laboratories Inc receiving its second warning letter from U.S. health regulators for unethical practices by the drugmaker’s sales representatives.