Posts Tagged: "FDA"

Until recently the Obama Administration had not taken any particularly strong or controversial stances with respect to intellectual property protection.  Sure, President Obama appointed a former RIAA attorney to a top spot in the Department of Justice, asked for study of open source initiatives for the federal government and has complained about counterfeiting and copyright infringement abroad.  On patent matters…

On Tuesday, March 10, 2009, Dr. Reddy’s Laboratories (NYSE:RDY) prevailed in a patent dispute with Astra Zeneca, receiving a summary judgment victory in the ongoing dispute before the United States Federal District Court for the Southern District of New York.  U.S. District Court Judge Colleen McMahon ruled that the Omeprazole Magnesium OTC Abbreviated New Drug Application (ANDA) filed by Dr. Reddy’s does not…

Despite the fact that an official announcement is not due until sometime later this morning, it seems likely that everyone already knows that President Barack Obama has selected Judd Gregg, the Senior United States Senator from New Hampshire, to be his Secretary of Commerce.  All the political pundits have offered expert commentary on why President Obama might choose a Republican Senator to…

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals, Inc. paid generic drug makers Watson Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. to delay generic competition to Solvay’s branded testosterone-replacement drug AndroGel, a prescription pharmaceutical with annual sales of more than $400 million. “At a time of escalating health care costs,…

Arcutis Pharmaceuticals, a privately held specialty pharmaceutical organization focusing in medical dermatology, announced yesterday that the United States Food and Drug Administration (FDA) has approved the new drug application (NDA) of Acanya Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) for the once-daily treatment of acne vulgaris in patients 12 years and older. Evaluated in clinical studies enrolling over 3,200 subjects…