FDA delays approval of Gilead HIV drugs
FOSTER CITY, Calif. — The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.
The drug maker said it received complete response letters from the FDA for elvitegravir and cobicistat; the FDA said it could not approve the regulatory applications for the drug in their current forms due to deficiencies in documentation and validation of some quality-testing procedures and methods found during recent inspections. The company said it was working to address the problems cited in the letters.
The FDA issues a complete response letter when it has finished reviewing an application, but problems found preclude the application’s approval in its present form.
Elvitegravir and cobicistat are components of Gilead’s single-tablet HIV drug Stribild (elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; tenofovir disoproxil fumarate 300 mg). The company said the FDA’s decision would not affect its authorization to market Stribild.
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Study: Vitamin D supplements important for baby but optimal daily dose in question
NEW YORK — A study in the May issue of the Journal of the American Medical Association released Tuesday found that vitamin D supplementation may be important for breast-feeding moms.
“Vitamin D is important during periods of rapid bone mineral accrual. Nursing infants are susceptible to vitamin D deficiency because vitamin D in breast milk is limited,” according to background information in the article. The report recommended vitamin D supplementation with at least 400 International Units per day, but cautioned against supplementing with amounts as high as 1,600 IUs per day.
The trial included 132 one-month-old healthy, term, breastfed infants. Researchers found that the percentage of infants achieving a primary vitamin D level differed at three months by group — for those taking 400 IUs per day, 55% achieved optimal vitamin D levels (defined as 75 nanomoles per liter of plasma); for 800 IUs per day, 81%; for 1,200 IUs per day, 92%; and for 1,600 IUs per day, 100%.
Bone mineral concentration increased over time for lumbar spine, femur and whole body but did not differ by group.
“Our primary objective was to establish a vitamin D dosage that would support [optimal vitamin D levels] or greater in 97.5% of infants at three months of age. Only the 1,600-IUs per day dosage of vitamin D met this criterion; however, this dosage was discontinued because most infants in that group developed elevated [vitamin D] concentrations that have been associated with hypercalcemia [higher-than-normal level of calcium in the blood],” the authors wrote. “Thus, the primary outcome was not achieved at three months."
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Planters Peanuts launches energy snack mix
NEW YORK — Planters Peanuts has launched a new snack mix with the aim to provide a sustaining boost of energy.
New Planters NUT-rition Sustaining Energy Mix is designed to provide wholesome fuel and is a good source of protein, fiber and four vitamins and minerals, according to the company.
Planters NUT-rition is available in three varieties:
- Apple Cinnamon — a blend of honey roasted peanuts, almonds, cinnamon soy clusters and dried apples;
- Chocolate Nut — a blend of honey roasted peanuts, candy coated dark chocolate soy nuts, honey soy clusters and almonds;
- Honey Nut — a blend of honey roasted peanuts, almonds, honey roasted cashews and honey soy clusters.
Planters NUT-rition Sustaining Energy Mix is available now on retail shelves nationwide.
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