Approval application withdrawn by Eli Lilly
INDIANAPOLIS Eli Lilly and Co. has withdrawn an application seeking approval from the Food and Drug Administration to market its antidepressant Cymbalta for treating chronic pain, the Indianapolis-based drug maker said Friday.
Citing a need for more data, Lilly said it plans to resubmit the application in the first half of next year for the added use of the drug.
“This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application,” vice president of Lilly Research Laboratories John Hayes said in a statement.
Cymbalta (duloxetine hydrochloride) is already approved for treating depression, anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia.
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.