FDA Alert Concerning Certain Cinnamon Products Due to Presence of Elevated Levels of Lead
March 7, 2024 – Through product testing, the FDA has determined that the ground cinnamon products listed in the table below contain elevated levels of lead and that prolonged exposure to these products may be unsafe. The FDA is advising consumers to throw away and not to buy these ground cinnamon products. The FDA has recommended that the firms voluntarily recall these products, with the exception of the MTCI cinnamon. The FDA...
FDA Says Popular Decongestant is Not Effective
September 13, 2023 – The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12 by unanimous vote declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the...
FDA Approves First Oral Treatment For COVID-19 In Adults
May 26, 2023 – Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults....
FDA Announces Recall Of Atovaquone Oral Suspension
April 3, 2023- Chamber Pharmaceuticals has recalled lot # E220182 of their Atovaquone Oral Suspension voluntarily due to the potential Bacillus cereus contamination within the product. FDA Risk Statement: Currently those at most risk are those who are immunocompromised, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as...
FDA Releases Draft Guidance For Labeling Plant-Based Milk Alternatives
March 3, 2023- The FDA released a Draft Guidance Feb. 22 to help ensure appropriate labeling of plant-based products that are marketed and sold as alternatives to milk. This draft guidance will provide industry with recommendations that will result in clear labeling to fill consumers with information to help them better understand plant-based milks. It also states PBMA (Plant-Based Milk Alternatives) with common and usual names have...
FDA Approves New HIV Drug For Adults With Limited Treatment Options
News Release Today (Dec. 22, 2022), the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. After the starting dose is completed, Sunlenca is administered as...
FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer
News Release — Dec. 16, 2022 Today, the U.S. Food and Drug Administration approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. “This...
USFDA Authorizes Bivalent COVID-19 Vaccines For Children Down To 6 Months of Age
FDA NEWS RELEASE — December 8, 2022 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. “More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to...
FDA Approves First Gene Therapy To Treat Adults With Hemophilia B
FDA News Release This week, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. “Gene therapy for hemophilia...
FDA Approves First Drug That Can Delay Onset Of Stage 3 Type 1 Diabetes
News Release — Nov. 17, 2022 The U.S. Food and Drug Administration Thursday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of...
