K-V to ship first product since 2009 manufacturing problems
ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.
K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.
Ethex, K-V’s generic drug marketing and distribution division, pled guilty in February to two felony counts of failing to file alerts to inform regulators of manufacturing problems in 2008, and agreed to pay $27.6 million to the federal government to resolve the investigation. The settlement allowed K-V to continue manufacturing drugs once it had regained compliance with the FDA’s current good manufacturing practices regulations.
In March 2009, the FDA filed an injunction against K-V to prevent it from making or distributing adulterated and unapproved drugs, and forced the company to destroy the drugs it had recalled, forbidding it from resuming manufacturing until it had been brought back into compliance with regulations.
“Today marks a significant milestone in our efforts to restore business operations at K-V,” interim president and CEO Greg Divis stated. “The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current good manufacturing practices requirements.”
The Apothecary Shops earns spot on Inc.’s fastest-growing private companies list
PHOENIX Diplomat Specialty Pharmacy isn’t the only one to earn a spot on Inc. magazine’s list of the fastest-growing private companies.
The Inc. 5000 also listed specialty pharmacy The Apothecary Shops, ranking 2,394. That marked a jump of 322 spots from last year and 1,682 spots from 2008 in its fourth annual appearance on the list.
Drug Store News reported Thursday on Diplomat’s inclusion on the list.
“It’s no secret that we have undertaken a very aggressive growth strategy for The Apothecary Shops, but our approach, particularly in a down economy, has been targeted and strategic to be in a solid position to leverage that growth when the economy turns,” The Apothecary Shops president Keith Cook said. “Our movement on the Inc. 5000 list of fastest-growing companies reflects the success of our strategic direction.”
Type 2 diabetes linked with cognitive impairments, study shows
WASHINGTON A small study conducted by Canadian researchers found factors that may link Type 2 diabetes with such cognitive impairments as dementia.
Older adults with diabetes who also have high blood pressure, walk slowly or lose their balance, or believe they’re in bad health, are more likely to have poorer cognitive functions than those without these problems, according to a new study conducted by researchers at the University of Alberta in Canada and published in the September issue of Neuropsychology
The study of older Canadians — 41 adults with Type 2 diabetes, ages 55 to 81 years, and 458 matched healthy controls (ages 53 to 90 years) — found that systolic blood pressure, a low combination score for gait and balance, and a patient’s own reports of poor health all played a statistically significant role in the relationship between diabetes and cognitive impairment.
“Awareness of the link between diabetes and cognition could help people realize how important it is to manage this disease, and to motivate them to do so,” said co-author Roger Dixon, PhD, of the University of Alberta.
Type 2 diabetes has been found by other researchers to nearly double the risk of dementia and Alzheimer’s disease, said Dixon, who studies how health affects cognition in aging. As diabetes becomes more common, this heightened risk could dramatically hike the number of older people with dementia.
The prevalence of diabetes in the United States for people older than age 60 — according to the National Institute of Diabetes and Digestive and Kidney Diseases — is more than 23%, while Canadian prevalence is nearly 19%, according to the Public Health Agency of Canada.