FDA approves Uceris for ulcerative colitis
SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.
Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.
"We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis," Santarus president and CEO Gerald Proehl said. "With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013."
Proehl said the company expected the drug to have sales of $320 million to $325 million.
FDA sets generic drug user fee rates for 2013
SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.
The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.
The fees for domestic factories making final dosage forms and active pharmaceutical ingredients are $175,389 and $26,458, respectively. For foreign factories, the fees are respectively $190,389 and $41,458.
The agency said that under the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the fee for a factory outside the United States should be $15,000 to $30,000 higher than the fee for a domestic factory.
The FDA said it calculated the fee using data submitted by generic drug facilities through the self-identification process mandated under GDUFA.
NACDS prepares for Total Store Expo
The National Association of Chain Drug Stores is putting all the pieces in place in anticipation of its inaugural Total Store Expo to be held this August in Las Vegas.
The new Expo combines the NACDS’ Supply Chain and Logistics, Marketplace, and Pharmacy and Technology conferences all into one show and in so doing facilitates a more comprehensive collaboration between retailers and suppliers. “It’s allowing us to bring ancillary synergies or permutations from the industry into Total Store Expo,” noted Jim Whitman, SVP member programs and services at NACDS. “When you look at the business of our industry right now, whether it be packaging, introducing new products, appealing to the consumer — there’s so many overlapping departments and considerations involved. The Total Store Expo is going to be on the cutting edge in bringing those people [across all those disciplines] together.”
And while executives dealing in supply chain, the front-end and pharmacy will be enabled to construct a new kind of retail-supplier partnership, NACDS is still putting together a program that appeals to each of those disciplines individually. “There are certain common elements like the trade floor,” Whitman said, while business sessions and educational content specific to each group will occur concurrently. “The advantage of it is we will be able to bring the various disciplines together in a format that will [help] expand knowledge in other areas of the industry.”
Already 75% of the floor space — encompassing the entirety of the Sands Expo Center at the Venetian Hotel Las Vegas — is accounted for. “That’s interesting in the fact that we’re nine months out, [and] committing to something in August 2013 [now] is a testament to the excitement of the Total Store Expo,” Whitman said.
NACDS over the past few years has been on the cutting edge in introducing new interactive conference technology to its various show floors. And Total Store Expo will be no different, Whitman noted. “We’ve been on the forefront of having a mobile app for all of our conferences for the past three-plus years, and we will continue with that,” he said. “As technology becomes better, it’s reflected in our app.”
New for Total Store Expo, suppliers preparing for the Expo can access an interactive show floor map at TSE.NACDS.org that is updated daily. With that map, NACDS staff can help suppliers identify an optimum space over the phone.