Labopharm reviewing notification of Actavis’ approval application for generic Oletpro
LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.
The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.
Actavis’ application contained a Paragraph IV certification, a legal challenge to a Labopharm patent covering the drug, which expires in June 2020. The market exclusivity period, which prevents the FDA from approving Actavis’ version, expires in February 2013.
Labopharm said it was reviewing the letter to determine what steps to take, though under the Hatch-Waxman Act of 1984, it is allowed to file a lawsuit against Actavis to prevent the latter from marketing its generic version of the drug.
Pharmacists engage with patients in campaign for improved nutrition
Should retail pharmacists tell their patients to eat a good breakfast?
A mountain of data showing the health benefits of a good breakfast — one that includes high-fiber foods like cereals and grains — point to an unequivocal answer: absolutely.
Studies have proven that eating breakfast is closely linked to healthy body weights, improved mental alertness and physical performance. Plus, people who skip breakfast don’t make up for the missed nutrients later in the day.
And with health and nutrition concerns influencing more household food purchases in the United States, pharmacists are increasingly helping patients learn about better dietary choices while they shop.
As a result, retail pharmacies are equipping pharmacists with additional training and education to encourage discussions with customers about overall nutrition, including the importance of starting the day with breakfast.
“As the category leader, Kellogg Company’s integrated shopper insights team helps our customers better understand what shoppers are looking for and how they shop the category,” says Doug VanDeVelde, SVP marketing and innovation of ready-to-eat cereal for Kellogg. “We also have a number of efforts under way to remind consumers of the significant benefits of cereal. For example, at www.loveyourcereal.com, we share important nutrition information and address some common consumer questions about ready-to-eat cereal.”
Price-conscious consumers are also looking for discounts, as well as products that offer good nutrition — and at just 50 cents a serving, including milk, cereal provides convenient, affordable nutrition for families.
In fact, ready-to-eat cereal is growing approximately three percent per year and is the third largest center-of-the-store category.
Moreover, cereal provides important nutrition for people at all life stages. Cereal helps children get valuable nutrients they might otherwise miss. For women of childbearing age, cereal provides necessary iron, calcium, fiber and folic acid. And the nutrient density of cereal helps elderly people get necessary nutrients for relatively few calories, which is important as calorie needs decline, but nutrients needs do not.
With healthier food selections, nutritional information and in-store pharmacists, supermarket pharmacies are fertile ground for a more integrated approach to health and wellness.
“If there’s an actual dietitian or a nutritionist in the store, more and more we’re seeing the pharmacist create in-store programs with the dietitian,” said Cathy Polley, VP health and wellness for the Food Marketing Institute and executive director of the FMI Foundation. “They’re collaborating to make sure they understand each other’s world a little better and give the consumer a healthier lifestyle and more fulfilling shopping experience.”
For example, when a person with diabetes or high cholesterol arrives to fill a prescription, the pharmacist can suggest programs, cooking classes or tours led by the dietitian that may complement a patient’s medication.
In addition, Polley told Drug Store News, “Many of the grocery manufacturers these days also have products that they are displaying in and around the pharmacy, like fiber bars and different types of cereal. That really lends itself to pharmacists being able to make that nutrition discussion part of their counseling about the medication.”
There is strong evidence that diets higher in fiber help reduce the risk of a number of health issues, such as heart disease, obesity, diabetes and certain cancers, yet 90 percent of American adults and children aren’t getting enough fiber in their diets. Kellogg is also helping consumers with this important need. The majority of its cereals are at least a good source of fiber (3 grams), and about half also include a half serving (8 grams) of whole grains.
Together, pharmacists, retailers and manufacturers are helping educate consumers about important nutritional options, as well as the benefits breakfast brings to the table. And with more than 80 cereal choices, Kellogg provides consumers with nutritious, convenient and affordable breakfast options that help meet their taste preferences and nutrition needs.
Return to Taking Back Breakfast
NCPA’s new chief likely to shift focus to the Hill
ALEXANDRIA, Va. — The natural affinity that has sprung up between independent pharmacy and the generic drug industry — both viewed as underdogs in the relentless fight for market position and profits: one versus powerful chain and big-box retailers, the other versus the far more entrenched and well-funded branded drug industry — was never more fully realized than it was at the end of October, when the National Community Pharmacists Association introduced its new top manager to its members at the group’s annual meeting.
The NCPA’s new EVP and CEO is Kathleen Jaeger, formerly head of the Generic Pharmaceutical Association. Jaeger, a coolly competent industry spearhead and Washington insider, will bring a markedly different leadership style to the independent pharmacy group than that of her predecessor, the able Bruce Roberts, who retired in June. Both are pharmacists; Jaeger, like Roberts, is steeped in the allure of community pharmacy and is the daughter of an independent pharmacist, as well as a pharmacist by training. But where Roberts brought passion borne of long experience operating his own pharmacies to his role as the face of independent pharmacy, Jaeger likely will put a different stamp on the NCPA.
A lawyer as well as a pharmacist by training, Jaeger has the kind of inside-the-Beltway contacts and legal credentials that the organization may need at this stage of its long existence. Before taking command of the GPhA eight years ago, she honed her Washington chops by chairing the Food and Drug Practice for the McKenna and Cuneo law firm and for Kirkpatrick and Lockhart.
While at the GPhA, she worked hard to win respect and visibility for generic drugs and their manufacturers among the public and on Capitol Hill. And that’s exactly the kind of advocacy that the NCPA needs—particularly in this unsettled time of rapid change and uncertainty as the massive reforms coming to the U.S. healthcare system begin to work their way through every facet of professional practice, including pharmacy.
It’s no secret that independent community pharmacies have been hit particularly hard by this brutal recession—not to mention by the longer-term challenges that preceded it, like the steady erosion of pharmacy profit margins. But their role still is a critical one, especially in rural areas where big chains don’t tread. And that’s to say nothing of their economic importance as the small, locally owned businesses that every economy needs in order to thrive.
Jaeger’s experience at the GPhA and as a second-generation pharmacist is a big asset for the NCPA, and if she can replicate her GPhA successes there, then independent pharmacies across the country are likely to benefit as well.