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Aurobindo Pharma’s ANDA of olanzapine orally disintegrating tablets approved

BY Michael Johnsen

HYDERABAD, India — Aurobindo Pharma on May 15 gained approval to produce a generic version of olanzapine orally disintegrating tablets in 5-mg, 10-mg, 15-mg and 20-mg strengths. The drug is the generic version of Zyprexa Zydis tablets from Eli Lilly.

The drug is used for the treatment of schizophrenia or bipolar I disorder. 

Olanzapine orally disintegrating tablets had U.S. sales of $120.8 million for the 12 months ended March 31, according to IMS Health.

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American Academy of Pediatrics: Iodine found lacking in the diets of pregnant and breast-feeding women

BY Michael Johnsen

ELK GROVE, Ill. — The American Academy of Pediatrics on Monday reported that many pregnant and breast-feeding women in the United States may be lacking iodine in their diets, which is an essential element for their babies’ brain development, according to a new policy statement, “Iodine Deficiency, Pollutant Chemicals, and the Thyroid: NewInformation on an Old Problem,” published in the June 2014 issue of Pediatrics

In the policy statement, the AAP recommends iodine supplementation for breastfeeding mothers and should be considered for some other women of childbearing age, and recommends that young infants not be exposed to tobacco smoke or drinking water with excess nitrate. 

“We are encouraged by the new report from the American Academy of Pediatrics that both recognizes the vital role of iodine in the development of a baby’s nervous system, and recommends that pregnant and lactating women take a supplement containing iodide, a form of iodine easily absorbed by the body, to garner those benefits," stated Duffy MacKay, SVP scientific and regulatory affairs for the Council for Responsible Nutrition. "CRN urges vitamin and supplement manufacturers to review and consider the specific recommendations from the American Academy of Pediatrics with regard to dose and iodine form, and our association will be taking these recommendations under advisement to discuss with our member companies." 

MacKay drew the correlation between what’s happening with iodine today and folic acid from several decades ago, when folic acid was found to play a critical role in reducing neural tube birth defects, like spina bifida. "We see similarities between the folic acid story and what is now happening with iodine, and hope that the same groundswell will develop for educating women of childbearing age of the critical importance of iodine in helping ensure optimal cognitive development in babies," MacKay said. 

Most of the salt in the U.S. diet is from processed foods, and that salt is not iodized. As consumption of processed foods has increased, so has the level of iodine deficiency, with about one-third of pregnant women in the U.S. being deficient. Pregnant and lactating women should take supplements that contain adequate levels of iodine, but only about 15% of this group does so, AAP reported.

Adequate iodine intake is needed to produce thyroid hormone, which is critical for brain development in children. Severe, untreated hypothyroidism in infancy has serious, permanent effects on the brain, and milder cases of hypothyroidism can also affect a child’s cognitive development. In addition, iodine deficiency in a mother increases both mother and child’s vulnerability to the effects of certain environmental pollutants — most notably thiocyanate (found in cruciferous vegetables and tobacco smoke) and nitrate (found in certain leafy and root vegetables). Perchlorate, an environmental pollutant found in about 4% of public drinking water supplies and in a few foods is an additional concern. 

The AAP calls for better and more accurate labeling of supplements to reflect the actual content of iodine. The statement also calls on the federal government to complete a national primary drinking water regulation for perchlorate, and calls on state and local governments to enact clean-air and smoke-free legislation and ordinances.

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Gallup poll: Self-reported obesity rates higher

BY Michael Johnsen

WASHINGTON — According to a Gallup poll released last week, the adult obesity rate is 27.7% thus far in 2014. This compares with the 27.1% average in 2013 — the highest annual rate Gallup and Healthways have measured since beginning to track obesity in 2008.

"While it is difficult to identify long-term trends from short-term data, these data suggest, at best, no retreat in the obesity epidemic and, at worst, a deterioration," stated Janna Lacatell, Healthways Lifestyle Solutions director. "Given that obesity leads to higher rates of serious health conditions like diabetes and hypertension, and has been shown to cause disease onset at younger ages, this is a significant public health concern. Further, populations that have a disproportionately high obesity rate, such as African Americans and southerners, also have disproportionately higher diabetes rates."

The Gallup-Healthways Well-Being Index, which uses respondents’ self-reports of their height and weight to calculate body mass index scores, differs slightly from government reports of obesity, which are based on actual heights and weights found in clinical measurements. For the past six years, nearly two-thirds of Americans have had BMIs higher than are recommended, while roughly 35% of Americans have been in the "normal weight" category.

A little more than one-in-three Americans (35%) are classified having a normal weight so far in 2014, while 35.3% of adults are considered "overweight." Meanwhile, underweight Americans make up a very small 2.1% of the adult population.

The obesity rate was 25.5% in 2008 when Gallup and Healthways first began tracking it. The percentage of obese adults has fluctuated since then, but is now 2.2 percentage points higher than it was in 2008.

Across major demographic categories, obesity rates are higher or stable thus far in 2014 compared with 2013. As has previously been the case, blacks (35.5%) are the most likely to be obese among all demographic groups. Meanwhile, young adults aged 18 to 29 years (17%) and high-income Americans (23.1%), those who earn $90,000 or more annually, remain the groups least likely to be obese.

The obesity rate among older Americans aged 65 and older ticked up 1.6 points so far in 2014 to 27.9%, the largest increase among subgroups.

 

 

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