USFDA

FDA approves new treatment for a type of heart failure

  • Posted on: 6 May 2020
  • By: PharmaTutor News

The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Heart failure occurs when the heart does not pump enough blood to support the body’s needs, and this type of heart failure happens when the heart’s main pumping chamber, the left ventricle, is weakened. With the approval, Farxiga is the first in this particular drug class, sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns

  • Posted on: 30 April 2020
  • By: Shalini.Sharma

U.S. Food and Drug Administration provided an update on its efforts to ensure the availability of alcohol-based sanitizer to help meet the demand for hand sanitizer during the COVID-19 pandemic. As a result of the agency’s significant flexibility, more than 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. At the same time, the agency is addressing safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims.

Glenmark Pharmaceuticals receives ANDA tentative approval for Dapagliflozin and Saxagliptin Tablets

  • Posted on: 29 April 2020
  • By: PharmaTutor News

Glenmark  Pharmaceuticals  Inc.,  USA  (Glenmark)  has  been  granted tentativeapproval by the United States Food & Drug Administration (U.S. FDA) for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern®1Tablets, 10 mg/5 mg, of AstraZeneca AB.

FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems

  • Posted on: 25 April 2020
  • By: Shalini.Sharma

U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.

FDA Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction

  • Posted on: 25 April 2020
  • By: Shalini.Sharma

The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). This action is a continuation of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.

FDA Authorizes First Test for Patient At-Home Sample Collection

  • Posted on: 25 April 2020
  • By: Shalini.Sharma

The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments

  • Posted on: 25 April 2020
  • By: Shalini.Sharma

U.S. Food and Drug Administration granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body. Patients must have received at least two prior therapies before taking Trodelvy.

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

  • Posted on: 16 April 2020
  • By: Shalini.Sharma

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators

  • Posted on: 13 April 2020
  • By: Shalini.Sharma

The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

Pages