Mylan sued for alleged patent infringement
PITTSBURGH Three drug companies have sued Mylan over an approval application the generic drug maker filed with the Food and Drug Administration for a version of the muscle relaxant Amrix, Mylan said Monday.
Mylan confirmed that Cephalon, Eurand and Anesta had sued it in connection with its application in the United States District Court for the District of Delaware, alleging an infringement of U.S. Patent No. 7,387,793.
Amrix is known generically as cyclobenzaprine hydrochloride. Mylan intends to market an extended-release formulation of the drug, which had sales of $53 million for the 12 months ending Sept. 30, according to IMS Health.
NOCA recognizes PTCB’s Corrigan with Certification Industry Leadership Award
WASHINGTON Melissa Murer Corrigan, executive director and chief executive officer of the Pharmacy Technician Certification Board, has received the 2008 Certification Industry Leadership Award from the National Organization for Competency Assurance, PTCB announced Tuesday.
PTCB said the award recognized Murer Corrigan’s leadership in the field of certification and licensure. She has certified more than 320,000 pharmacy technicians as the founding executive of PTCB.
“This award is a tribute to the hard work and dedication of all my colleagues and partners involved in making PTCB a success since our founding in 1995,” Murer Corrigan said in a statement. “The certification of pharmacy technicians in the U.S. has advanced the patient safety of millions of Americans, and I am so proud of the PTCB team and all of our certified technicians.”
FDA warns Shionogi to end unsupported Cedax claims
ROCKVILLE, Md. The Food and Drug Administration released a warning letter to Shionogi and Co. Tuesday regarding its antibiotic Cedax.
The FDA said the company made inflated claims about Cedax (ceftibuten) and downplayed the health risks associated with it. Promotional materials sent to doctors claimed the drug had “excellent tolerability,” even though data did not support the claim.
The drug is approved for treating mild to moderate bacterial infections.