FDA extends timeline for Dysport application review
PARIS The Food and Drug Administration has notified Ipsen that it has extended the Prescription Drug User Fee Act action date for the company’s approval application for using botulinum toxin drug Dysport to treat cervical dystonia to no later than Dec. 28, Ipsen said Tuesday.
The company said the FDA’s decision would not affect the timing of its launch plans, and the agency had not requested any additional safety or clinical studies for review.
“We are assembling the requested information from the dossier, in close coordination with the FDA,” Ipsen, executive vice president for corporate development Stephane Thiroloix, said in a statement.
The FDA has given Dysport orphan product status as a treatment for cervical dystonia, a muscular disorder that affects the neck and shoulders.
FDA examines anemia drugs used to treat stroke victims
WASHINGTON Use of anemia drugs from Amgen and Johnson & Johnson to treat stroke patients has come under scrutiny by the Food and Drug Administration following studies showing the experimental use leading to higher premature death rates, the FDA said Friday.
A German study designed to determine whether J&J’s drug Procrit (epoetin alfa) could improve cognitive function in stroke patients found that more patients taking the drug died prematurely than those taking a placebo. Amgen sells a version of the drug under the brand name Epogen.
Senate OKs military spending bill extending TRICARE pharmacy choice
WASHINGTON Community pharmacy’s long campaign for a level playing field to fill prescriptions for military members and their families is nearing the finish line, thanks to passage in the Senate of a massive military spending bill.
Over the weekend, the Senate passed the House-Senate negotiated version of S. 3001, the National Defense Authorization Act for Fiscal Year 2009. The bill includes an important provision to preserve pharmacy choice for TRICARE beneficiaries.
The House passed S. 3001 last week. If signed into law by Pres. Bush, the bill would preserve the right of U.S. military members and their families to choose where they have their prescriptions filled with passage of a newly revised military spending bill.
The provision would extend the current freeze on increases to retail pharmacy co-payments, thus maintaining a level playing field for retail pharmacies vis-a-vis mail-order pharmacies. Chain and independent pharmacy advocates fought a long struggle to have that provision included in last year’s military spending bill, and were buoyed by its inclusion in this year’s proposal.
“We are pleased that the House and Senate have recognized the importance of choice and urge the President to act quickly to sign the bill,” commented Steven Anderson, president and chief executive officer of the National Association of Chain Drug Stores.