Valsartan Recall, Drug Approval for Smallpox



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This weekly video program provides our readers with a thorough review of the latest news, product approvals, FDA decisions, and more. Our review of the week is a must for pharmacy professionals.

Nicole Grbadano, Host: Hello and welcome to News Network . I'm Nicole Grbadano, your host for our pharmacy week review

US FDA officials alert health professionals and patients to the voluntary recall of several drugs containing the active ingredient valsartan, due to a impurity, NDMA, which was found in the recalled products, according to a report on Pharmacy Times.com .

NDMA is clbadified as probable carcinogen for humans based on laboratory test results. The presence of NDMA was unexpected and would be related to changes in the way the active substance was manufactured. Some companies recall all lots of unexpired products containing the valsartan ingredient provided by a third party. All drugs containing valsartan distributed in the United States do not contain the active pharmaceutical ingredient valsartan provided by this specific company. The supplier has stopped distributing its valsartan API and the FDA is working with affected companies to reduce or eliminate the impurity API valsartan of future products.

High school athletes are more likely to suffer a concussion than adult athletes, and they generally take longer to recover as well. This vulnerability creates increased concern around head injuries for children and adolescents who are physically active, according to a report published on Contemporary Clinic.com.

Yet, despite the known detrimental impacts that concussions have, especially on young brains, concussion rates are often underreported, according to CDC officials. This underreporting has recently prompted CDC researchers to badyze data from the National Youth Risk Behavior Survey (YRBS) to examine the prevalence of concussions among high school students, noting that 15.1% of students reported having suffered a concussion. last year. The numbers prompted CDC officials to encourage caregivers to remain aware of signs of concussion in younger patients during exams.

FDA officials approved tecovirimat (TPOXX, SIGA), the first drug. smallpox, to improve preparedness in case of bioterrorist attack, according to a report on Specialty Pharmacy Times.

Although it was eradicated in 1980 because of vaccination efforts, there was concern that the virus might be used as a potential weapon in bioterrorism. The FDA's approval is based on data from studies conducted on animals infected with viruses closely related to the smallpox virus.

The effectiveness of the drug was based on the measure of survival at the end of the study. According to the data, more animals treated with tecovirimat survived compared to animals treated with placebo. As a result, the drug has been approved under the FDA's Animal Rule, which allows efficacy results to support FDA approval when it is not possible or ethical to conduct tests at home. humans.

get more questions from their customers about safety in the sun. An educational video from FDA.gov aims to educate people about sun protection, urging viewers to use a broad-spectrum sunscreen with an SPF of at least 15. The video, titled FPS, Broad Spectrum, Water Resistance is available on Youtube. page.

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Thank you for watching our review of Pharmacy Week. My name is Nicole Grbadano at Pharmacy Times News Network.

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