FDA recommends approval of atrial fibrillation drug
PARIS The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 10-to-3 in favor of a drug by Sanofi-Aventis.
Sanofi announced Thursday that the committee favored approval of Multaq (dronedarone), a drug for treating patients with non-permanent atrial fibrillation, also known as AF, which affects around 2.5 million Americans and is the leading cause of hospitalizations for arrythmia in the United States.
The committee’s recommendations may influence the FDA’s decision whether to approve a drug, but they do not require the agency to give approval.
“Sanofi-Aventis is pleased with the outcome of today’s discussions and positive recommendation,” Sanofi chief medical officer Jean-Pierre Lehner said in a statement. “The panel’s insightful feedback which concluded with a positive vote is an important step in gaining FDA approval of Multaq.”
Drug Fair files Chapter 11; Walgreens to buy the stores
SOMERSET, N.J. Another regional player has fallen by the wayside, as Drug Fair files for Chapter 11 and enters an agreement to sell substantially all of its assets associated with 32 stores to Walgreens.
Prior to the bankruptcy filing, Drug Fair sold various assets at 13 locations to third parties, including Walgreens, which purchased prescription files from 11 Drug Fair locations that are closing. Patients previously served by these 11 pharmacies now have access to their prescription histories at any nearby Walgreens.
“Drug Fair has been a respected pharmacy in this region for more than 50 years,” stated Walgreens market VP for the Northeast, Tim Anhorn. “We’re pleased to be able to keep most of the stores open and continue providing these communities with convenient access to high quality pharmacy services and basic needs. Customers will continue to see many of the familiar faces behind the counter they trust for their healthcare needs.”
It is unclear when the acquisition will be finalized but, during the transition period, the day-to-day operations are expected to be uninterrupted at the locations that are to be sold as part of the proposed transaction with Walgreens.
In connection with the Chapter 11 filing, Drug Fair has arranged a four-month secured debtor-in-possession financing in the amount of $40 million. If approved by the court, proceeds from the DIP financing will be used by Drug Fair to fund its operations during the Chapter 11 proceedings and should enable it to continue to satisfy its obligations associated with its remaining operations, including payment of employee wages and benefits and post-petition obligations to vendors.
In a March 17 memo, Drug Fair president, CEO Tim LaBeau sent to associates, he wrote, “These challenging economic times have affected all of our families, our friends and our patients in some manner. As you have been well aware, our company too has been struggling to maintain its viability. To this end, rather than close our doors like others, we decided to initiate a process to find a buyer for our business who is in a better position to continue the Drug Fair legacy.”
As previously reported by Drug Store News, the two stores in Rockaway and Raritan Borough in New Jersey have already closed. The sign at the Raritan Borough store directs pharmacy patients to a nearby Wegman’s, which, according to local news reports, has acquired the prescription files from that location. The sign at the Rockaway store reportedly directs pharmacy patients to a nearby ShopRite.
U.N. calls for coordinated global approach to runaway market for Internet drug sales
VIENNA The United Nations is weighing more forcefully into the tangled web of the Internet-based prescription drug market.
On Tuesday, the agency’s International Narcotics Control Board unveiled a set of guidelines on how governments around the world can better regulate Internet drug sales, according to a report from Reuters.
The move comes amid an explosion in the growth of illegitimate, web-driven drug sales, and the need for a more integrated, global solution to the problem, according to the head of the Narcotics Control Board, Hamid Ghodse.
Addressing a U.N. conference here on anti-drug efforts here, Ghodse called for a more coordinated strategy among governments to deal with unregulated Internet drug sales, Reuters reported.