FDA gives tentative approval to pain medication from Cipher Pharmaceuticals
ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to a new drug for managing chronic pain, FDA records show.
The agency granted tentative approval to Mississauga, Ontario-based Cipher Pharmaceuticals’ CIP-Tramadol (tramadol hydrochloride) extended-release capsules in the 100 mg, 200 mg and 300 mg strengths. The drug uses patented controlled-release bead technology and features both extended-release and immediate-release properties, Cipher said in a statement.
“Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication,” Cipher president and CEO Larry Andrews said in a company statement. “We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues.”
Though several companies make generic versions of tramadol hydrochloride in the 50-mg strength, Johnson & Johnson still holds the patent on the three strengths for which Cipher seeks approval, marketing the drug under the brand name Ultram ER. Because of this, Cipher’s approval application to the FDA contained a paragraph III certification under the Hatch-Waxman Act, which means it will seek final approval for the drug after J&J’s patent expires in 2014. A paragraph IV certification, which would assert that J&J’s patent is invalid, unenforceable or would not be infringed upon, would likely provoke a patent-infringement lawsuit.
Three patients using psoriasis drug developed deadly infection, FDA says
ROCKVILLE, Md. Three patients, and possibly one more, using a biotech drug for treating psoriasis developed a deadly viral infection of the brain, according to a Food and Drug Administration advisory.
The FDA said Thursday that three patients taking Genentech’s drug Raptiva (efalizumab) for more than three years developed progressive multifocal leukoencephalopathy and died. One more may have developed the disease. None were receiving other treatments that suppress the immune system.
In October, the labeling for Raptiva was revised to highlight in a boxed warning the risks of dangerous infections, including PML. The drug works by suppressing T-cells.
PML results from an opportunistic infection by the JC virus, causing irreversible decline in brain function and death in people with severely weakened immune systems. According to the National Institutes of Health, most people carry the JC virus, though it is harmless to those with healthy immune systems.
The agency is reviewing the reports and has said it will ensure that the risks of Raptiva do not outweigh its benefits, that patients receiving the drug are clearly informed of the signs and symptoms of PML and that healthcare professionals carefully monitor patients for possible development of the disease.
NACDS chairman Giancamilli urges Canadian retailers to unify
TORONTO In a deft display of cross-border diplomacy, National Association of Chain Drug Stores chairman Andy Giancamilli today made common cause with Canadian pharmacy operators while urging them to adopt some of the same grassroots lobbying strategies now wielded by their American counterparts.
Giancamilli, the Kmart and Perry Drug Stores veteran who is CEO of Canada’s largest drug store network, Katz Group North America, and its U.S. subsidiary, Minnesota-based Snyder’s Drug Stores, is no stranger to pharmacy and general merchandise retailing on either side of the border. Addressing the Canadian Association of Chain Drug Stores’ Chain Drug Conference 2009 here this morning, he made good use of that dual-country perspective.
“It’s worth the dialogue to consider how each country can improve the health care of its citizens. And each country can learn from each other,” Giancamilli told CACDS members in an appearance that coincided with Pres. Barack Obama’s first trip to Canada since his inauguration last month.
Recapping the state of pharmacy retailing in the U.S., NACDS’ chairman told conference-goers that their American counterparts are staging an increasingly coordinated battle to educate policymakers and lawmakers on retail pharmacy’s concerns — and to win their support for pharmacy-friendly legislation and regulations.
“We are encouraging NACDS members to be the face of pharmacy in the minds of lawmakers,” Giancamilli said. “Just this month, NACDS launched RxIMPACT. This is the brand name for everything we do in the area of pharmacy tours for legislators, helping NACDS members write to their elected officials, arranging Congressional meetings for NACDS members in Washington DC, and more.
“RxIMPACT is the way for NACDS and allies to take a stand for better healthcare in a very personal way,” Giancamilli added. “Humbly, I would propose that CACDS and all provincial pharmacists’ associations replicate parts of RxIMPACT here.”
The chain pharmacy veteran said pharmacy owner/operators in Canada could benefit if they “engage more dialog with members of Parliament” through “grassroots communications and mobilization.”
Giancamilli acknowledged the global economic meltdown now dogging retailers on both sides of the U.S.-Canada border, but reminded his listeners of some advice from Pres. John F. Kennedy. “When uncertainty and crisis appear, the words of President John F. Kennedy are many times cited,” Giancamilli said. “He said, ‘The Chinese use two brush strokes to write ‘crisis.’ One brush stroke for danger, the other for opportunity. In a crisis, be aware of the danger, but recognize the opportunity.’
“That’s what were are here to do, and I say let’s go!” Giancamilli added.