FDA issues not approvable letter for gepirone
HOUSTON, LONDON, and RESEARCH TRIANGLE PARK, N.C. The Food and Drug Administration has issued a not approvable letter for Fabre-Kramer Pharmaceuticals and GlaxoSmithKline’s new drug gepirone extended-release.
The drug is used to treat adults with major depressive disorder. This decision is a result of the FDA reviewing information from a short-term trial it asked the companies to perform after first reviewing the drug in 2004.
The results from the additional trial were submitted to the FDA in May. The FDA made its decision based on the initial clinical data, which had information from Phase I to III data and on the new short-term trial.
The two companies entered into an agreement in February for the worldwide development and commercialization of the drug and are now evaluating the response from the FDA to determine what steps should be taken.
AVI gets fast-track status from FDA for DMD drug candidate
WASHINGTON The Food and Drug Administration has granted fast-track status to drug developer AVI Biopharma’s product candidate for Duchenne muscular dystrophy, a fatal genetic disorder in children, the Associated Press reported.
Duchenne muscular dystrophy is an incurable muscle-wasting disease, caused by a mutation in a person’s dystrophin gene. The result is membrane leakage and fiber damage, leading to degeneration and death of the muscle fiber. About one in 3,500 boys is born with it, and roughly 15,000 to 20,000 children have DMD in the U.S., according to AVI.
The status means a company can submit data to the FDA as it becomes available and receive agency feedback, rather than having to wait and turn it in all at once. AVI plans to initiate a clinical trial with its drug candidate by mid-2008 to evaluate the safety and effectiveness of the drug in DMD patients who can still walk on their own.
FDA investigation suggests online drug sales driven by lax prescription rules
WASHINGTON A yearlong Food and Drug Administration investigation has found that consumers may be purchasing drugs online to avoid the need for a prescription from their physician.
Although several drugs are mailed to the United States from foreign countries more often than not, the FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.
The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Among the remaining products were dietary supplements, foreign products with “incomprehensible labeling”, and some were medications not available in the United States.
The FDA stressed the risk of purchasing drugs online, as they may be a front for an illegal operation. Unregulated Internet drug sellers, they said, might have products which might not contain the correct ingredients and could contain toxic substances.
“The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription,” said Randall Lutter, FDA’s deputy commissioner for policy. “In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice.”
Meanwhile, more than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. Approved generic versions of nearly half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. The FDA then recorded data on the contents of these packages, before handling them in accordance with its usual procedures.