FDA ruling on opioid painkiller deals blow to Endo
SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.
The FDA responded to a petition filed by Endo, a subsidiary of Endo Health Solutions, saying that an earlier version of the drug Opana ER (oxymorphone hydrochloride) was not withdrawn from the market due to reasons of safety and effectiveness because, unlike the newer version, it did not include abuse-deterrent features. The agency said that while the newer version of Opana ER can resist crushing better than the older version, it is still susceptible to abuse by cutting, grinding or chewing, and various methods would still allow its abuse through injection or snorting.
In December 2012, the U.S. District Court for the District of Columbia dismissed a case that Endo filed against the FDA, alleging that the agency had failed to fulfill an obligation to determine whether the original version of Opana ER was withdrawn for safety reasons, clearing the way for Impax Labs’ January 2013 launch of the generic.
The abuse-deterrent version of the drug was launched in early 2012, and in February, when Endo announced its fourth quarter 2012 earnings, the company said the new version had reduced the abuse rate by 59%.
Malvern, Pa.-based Endo said it was "extremely disappointed" with the decision. The company said the launch of generic versions of Opana ER would reduce the branded version of the drug’s sales by up to $120 million this year. The drug had sales of $299.3 million in 2012, down 22% from 2011’s $384.3 million, according to Endo.
"With the approval and expected launch of additional non-abuse deterrent generic versions of Opana ER, we will carefully assess Endo’s position in the competitive landscape and explore all options, including those intended to mitigate the effect of this decision," Endo president and CEO Rajiv De Silva said. "Endo remains committed to patient safety, including appropriate use of our products, as a top priority."
Meanwhile, the FDA reached a different conclusion with regard to generic versions of another commonly abused opioid painkiller, Purdue Pharma’s OxyContin (oxycodone). In April, the agency said it would not approve any generic version of OxyContin that did not include the abuse-deterrent features of the branded version.
Butterball introduces line of turkey meat snacks
MEMPHIS, Tenn. — Butterball has entered a licensing agreement with Monogram Food Solutions, LLC, a Memphis, Tenn.-based manufacturer of processed meat, to launch a new line of turkey meat snacks featuring jerky, turkey bacon jerky, turkey nuggets and turkey snack sticks.
"We are excited about our partnership with Monogram, a leader in the meat snacks industry, who will be using Butterball turkey in a new, innovative meat snack offering," said Bill Klump, senior vice president of corporate marketing with Butterball, LLC. "We look forward to introducing these high-quality, delicious turkey meat snacks to customers and consumers."
Monogram is gearing up to add turkey protein to its operation in Chandler, Minn., with the production of Butterball turkey meat snacks. Production begins in May for the following variety of new turkey meat snacks:
- Butterball Apple Turkey Nuggets – made with pieces of sweet dried apples;
- Butterball Turkey Bacon Jerky – crisp, with smoky hickory notes;
- Butterball Teriyaki Turkey Jerky – sweet with savory soy sauce;
- Butterball Oven Roasted Turkey Jerky – full of Thanksgiving flavor.
"Butterball is an iconic national brand with a tremendous heritage," said Wes Jackson, president of Monogram Food Solutions. "We are honored to be working hand-in-hand with the folks at Butterball to bring premium turkey into the meat snack section with these healthy, great tasting products."
New Butterball Turkey Meat Snacks offer customers a better-for-you, lean protein product in the meat snack category, currently dominated by beef jerky (95%). Butterball Turkey Meat Snacks have no added MSG, are low-fat, low-calorie, low-carb and high in lean turkey protein, and at 220 mg/ounce, Butterball Teriyaki Turkey Jerky has less than half the sodium found in most national brands of beef jerky (550-600mg), according to the company.
Monogram will round out the new Butterball Turkey Meat Snack line with Turkey Snack Bites and snappy Giant Smoked Turkey Snack Sticks, all made with lean, nutritious Butterball turkey.
These products will hit retail and convenience store shelves nationwide this summer.
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Commerce Dept.: Health, personal care store sales up year-over-year, year-to-date sales down slightly over 2012
WASHINGTON — Seasonally adjusted retail sales increased by 0.6% in April over last year, while unadjusted retail sales increased 3.9%, according to numbers released Monday by the Department of Commerce.
The figures, which exclude cars, gas stations and restaurants, showed that retail sales for the month increased 0.1%.
"In the face of higher taxes and sequester, consumers provided the economy a bit of a reprieve this month," National Retail Federation president and CEO Matthew Shay said. "Despite colder spring weather and an early Easter, consumers shopped in April, demonstrating an inherent resiliency even as the economy faces serious headwinds, including stagnant job and wage growth."
The report did not include the latest figures for retail pharmacies in particular, but the health and personal care stores category showed sales of $22.693 billion, a slight uptick from last April’s $22.686 billion; the four-month total for the category of $91.5 billion represented a 0.5% decrease from the first four months of last year. Supermarkets had sales of $46.3 billion for the month, up from $46.1 billion the year before, while the four-month total of $188.1 billion was 2.2% higher than the same period last year.
Some analysts saw the data as a sign of good things to come for the retail industry.
"A meaningful sequential up-tick in April retail sales — from upwardly revised March results — is a clearly positive data point," Guggenheim Securities analyst John Heinbockel wrote in a note to investors, adding that dollar stores would have the best risk-reward profile in the sector. "We would also note that various discretionary categories strengthened while the more defensive consumables categories weakened. Given that weather, though better than prior months, was still challenging in April, spending momentum may well improve further over the next two months before moderating again."