FDA delays approval of GSK vaccine
LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.
GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.
The vaccine is designed for adults who are at risk of exposure to the H5N1 influenza virus. The program to develop the vaccine is supported by the Department of Health and Human Services’ Biomedical Advanced Development and Research Authority.
GSK said it was working with the agency to resolve the matter, and that the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to support approval of the vaccine.
FDA approves Actavis drug for opioid dependence
PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.
Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.
The drug is a generic version of Reckitt Benckiser’s Suboxone, which had sales of about $625 million in 2012, according to IMS Health.
NCPA among industry associations rejecting proposal to reschedule hydrocodone
ALEXANDRIA, Va. — The National Community Pharmacists Association last week called for the rejection of a proposal made by Sens. Joe Manchin, D-W.Va., and Mark Kirk, R.-Ill., to reschedule Vicodin and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act.
"Community pharmacists share concerns regarding the abuse and diversion of prescription drugs. Abuse of these drugs can ruin lives, devastate families and has contributed to dangerous crimes against pharmacies," stated NCPA CEO Douglas Hoey. "Aggressive anti-drug abuse efforts must be balanced with preserving legitimate patient access to necessary prescription drugs. This legislation, while well-intentioned, fails that test," he said. "It would create significant hardships for many and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings. Moreover, there are far more practical means available by which Congress and law enforcement can reduce prescription drug abuse without inflicting collateral damage on many innocent patients and the pharmacists caring for them."
Nearly 3,000 different combinations of strength, formulation and manufacturer of hydrocodone-containing products exist. Moving them to the more restrictive Schedule II could significantly delay patient access by eliminating phoned-in prescriptions, stopping prescription refills and, in some cases, prohibiting electronic prescribing. Higher healthcare costs would almost certainly result in order to account for increased physician interactions and other administrative burdens associated with Schedule II medications.
A group of patient and pharmacy groups including NCPA recently sent a letter to the Food and Drug Administration raising many of the same points. The letter was signed by American Academy of Pain Management, American Association of Nurse Assessment Coordination, American Cancer Society Cancer Action Network, American Society of Consultant Pharmacists, Amputee Coalition, CarsonCompany, Citizen Advocacy Center, Interstitial Cystitis Association, Long Term Care Pharmacy Alliance, Massachusetts Pain Initiative, NADONA, National Association of Chain Drug Stores, National Fibromyalgia & Chronic Pain Association, National Hospice and Palliative Care Organization, Pain Treatment Topics, US Pain Foundation and the Wisconsin Pain Initiative.
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