Ranbaxy receives FDA approval for generic migraine treatment
PRINCETON, N.J. A generic drug maker has received approval from the Food and Drug Administration to manufacture and market a popular migraine medication.
Ranbaxy Pharmaceuticals has received final approval from the FDA to manufacture and market sumatriptan succinate tablets in 25- and 50-mg strengths. The medication is the generic equivalent of Imitrex, a migraine treatment by GlaxoSmithKline. Total annual market sales for the tablets were $379 million, which is indicated for the acute treatment of migraine attacks with or without aura in adults.
“This product will be launched immediately to all classes of trade and further expands our product portfolio of affordable generic product formulations, that will be of benefit to patients, healthcare professionals and the U.S. healthcare system,” according to Bill Winter, VP trade sales North America at Ranbaxy.
Blue Cross Blue Shield of Illinois hits e-Rx milestone
CHICAGO Blue Cross Blue Shield of Illinois announced Monday that physicians and healthcare providers in the Illinois E-Prescribing Collaborative reached a major milestone in their e-prescribing efforts: the one millionth e-prescription transmitted. The Illinois Blues program also recorded the significant benefits of expanded use of electronic prescribing technology.
“E-prescribing enhances patient care and prevents errors,” said Scott Sarran, M.D., BCBSIL’s chief medical officer. “E-prescribing reduces the potential for drug interactions, which can be extremely harmful, and even fatal in some cases, and it can eliminate the potential for errors that can occur if pharmacists can’t read hand-written prescriptions.”
Sarran said that since BCBSIL launched the e-prescribing program in April 2007, more than 119,000 possible drug interactions have been flagged. As a result, nearly 20% of prescriptions were changed or cancelled.
Based on national trends, more than 670,000 prescriptions will be changed and cancelled in 2009, due to drug interaction warnings, and more than 53,600 prescriptions will be changed or cancelled due to drug allergy warnings.
The Institute of Medicine reports that more than 1.5 million Americans are injured every year by medication errors and recommends that all prescriptions be written and received electronically by the year 2010, BCBSIL said.
Surescripts, a St. Paul, Minn.-based national electronic prescribing network, said e-prescribing accounts for about 4.5% of all prescribing in the United States. However, since 2007, e-prescribing has more than doubled to 68 million in 2008 from 29 million in 2007.
Sarran said BCBSIL providers using the technology have increased. He has seen growth in the number of scripts routed electronically. According to the 2008 Electronic Prescribing Progress Report, Illinois ranked 21st in the nation for total number of prescriptions routed electronically. In 2007, the state ranked 28th and was 27th in 2006.
Watson Pharmaceuticals recalls fentanyl patches
MORRISTOWN, N.J. Watson Pharmaceuticals announced Monday that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies.
Watson’s Fentanyl Transdermal System CII is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.
The recalled patches are from Lot Number 145287A, have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma. The affected lot of patches was shipped to customers between April 2 and May 20 of this year. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall. The company has notified the Food and Drug Administration of the recall.
A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No serious injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
Patients using fentanyl patches who have medical questions should contact their healthcare providers.
Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.