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New Fuga energy drink hits retail shelves

BY Jason Owen

CHICAGO — A new energy drink made from natural yerba mate is hitting retail shelves now.

Fuga is a healthy energy drink made from the natural energy resource yerba mate which is said to offer the strength of coffee, the health benefits of tea and the euphoria of chocolate. Fuga’s array of herbal ingredients also includes prickly pear cactus, ginkgo biloba, guarana, milk thistle and acai, as well as essential vitamins and amino acids to support overall health and well-being.

Fuga is available in regular and sugar-free.

"Fuga is a Latin and Spanish term that means to ‘take flight’ which makes it the perfect name for our breakthrough energy drink because of its active, energetic and ascendant meaning," said Miguel Camarena , CEO at Aquarena Beverage. "When we started this company, we set out to create an energy enhancer that doesn’t overstimulate or make you feel jittery, but gives you just the right amount of consistent, long lasting energy from a healthy source. We succeeded in that mission and through our partnership with Rexam, we introduced it in a great-looking ‘Sleek’ can that will attract consumers’ attention."

Aquarena Beverage chose the Rexam "Sleek" can for Fuga because it helps the beverage stand out on retail shelves and is the most sustainable packaging choice in the world. Aluminum cans are recycled at more than double the rate of most other beverage packages, according to the company.

Rich Grimley, president and CEO, Rexam Beverage Can North America, says, "Our 12 oz. ‘Sleek’ can is extremely popular in the energy drink market because of its consumer appeal and the fact that it delivers superior environmental benefits as well as distribution and retail display economics. This makes it the perfect packaging solution to help Fuga establish their brand and build their business."

Fuga is available now at select retailers in Florida, Texas, California, New Mexico and Arizona.


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FDA delays approval of Gilead HIV drugs

BY Alaric DeArment

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

BY Michael Johnsen

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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