FDA Archives | STL.News

General

Two Akron-area men charged For Multiple Crimes

Two Akron-area men charged with intent to distribute approximately 10,000 THC vape cartridges and psilocin in Northern Ohio (STL.News) Acting U.S. Attorney Bridget M. Brennan announced today that a four-count indictment charging Gage Predojev, age 22, and Justin Duma, age 22, both of Akron, Ohio, with drug trafficking and firearm offenses was unsealed following the arrest of the defendants. Gage Predojev was charged with one count of possession with intent to distribute controlled substances (THC) and one count of felon in possession of a firearm. Justin Duma was charged with one count of possession with intent to distribute controlled substances (psilocin) and one count of possession of a firearm in furtherance of drug trafficking. In September of 2019, it is alleged that defendan...

General

Nationwide Telemedicine Pharmacy Health Care Fraud

Five New Guilty Pleas In Nationwide Telemedicine Pharmacy Health Care Fraud Conspiracy GREENEVILLE, TN (STL.News) Today, Larry Everett Smith, 50, of Tampa, Florida, pleaded guilty before Senior District Judge Ronnie Greer to one count of conspiracy to commit health care fraud. Sentencing has been set for October 25, 2021 at 3:00 p.m., in United States District Court in Greeneville. Smith faces a term of up to 10 years in prison. The First Superseding Indictment, returned December 1, 2020, charged Smith and others with a nationwide conspiracy to defraud pharmacy benefit managers out of $174,202,105 by submitting $931,356,936 in bills to the pharmacy benefit managers for fraudulent prescriptions purchased from a telemarketing company. The indictment alleges the conspiracy began in mid...

General

California Attorney General Joins Bipartisan Coalition Pushing FDA

Attorney General Becerra Joins Bipartisan Coalition Pushing FDA to Examine Progress in Opioid Fight SACRAMENTO, CA (STL.News) California Attorney General Xavier Becerra joined a bipartisan coalition of attorneys general today in urging the United States Food and Drug Administration (FDA) to provide an update on its current actions and information on the agency’s future work to help combat the opioid epidemic. Studies have shown that the COVID-19 crisis has fueled a devastating rise in overdoses with opioid deaths outpacing COVID-19 fatalities. To combat the opioid epidemic, the U.S. Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) in 2018. The law gave the FDA new authority and new requirements...

General

Justice Department Files Complaint to Stop Distribution of Unapproved, Misbranded, and Adulterated “Poly-MVA” Products

Justice Department Files Complaint to Stop Distribution of Unapproved, Misbranded, and Adulterated "Poly-MVA" Products (STL.News) The United States filed a civil complaint to stop a California company from distributing unapproved and misbranded drugs and adulterated animal drugs, the Department of Justice announced today. In a complaint for permanent injunction filed Dec. 2, 2020, the United States alleged that AMARC Enterprises Inc.; Albert Lee Sanchez Jr.; and Gary L. Matson Sr. sold and distributed “Poly-MVA” and “Poly-MVA for Pets,” which the defendants claim can cure, mitigate, treat, or prevent disease, including cancer. According to the complaint, defendants’ Poly-MVA products are not generally recognized as safe and effective by qualified experts for the uses intended by the d...

Business

Pfizer, BioNTech to submit Emergency Use Authorization to the US FDA – COVID-19

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date NEW YORK & MAINZ, Germany (STL.News) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) f...

Health

FDA Warning – Pain and Fever Medication – Pregnancy Complications

FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications Silver Spring, MD (STL.News) The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). These changes include new labeling to explain that if women take the medications around 20 weeks or later in their pregnancy, the drugs can cause rare but serious kidney problems in the unborn baby, which can lead to low levels of amniotic fluid (the protective cushion surrounding the unborn baby) and the potential for pregnancy-related complications. NSAIDs include medicines such as ibuprofen, naproxen, diclofenac, and celecoxib. People have taken these drugs for decades to tre...

Business

Pfizer and BionTech Granted FDA Fast Tract Designation

Pfizer and BionTech Granted FDA Fast Tract Designation for two Investigational MRNA-Based Vaccine Candidates Against SARS-COV-2 Anticipated large, global Phase 2b/3 safety and efficacy study may begin as early as July 2020 NEW YORK & MAINZ, Germany (STL.News) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA). BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical stud...

Business

Abbott receives FDA approval for new heart rhythm devices

Abbott receives FDA approval for new heart rhythm devices featuring Bluetooth connectivity and continuous remote monitoring Next-generation Gallant™ implantable cardioverter defibrillator family of devices offers Bluetooth® capability for a more meaningful connection between patients and their doctors Gallant ICD and CRT-D devices feature a patient-preferred design without compromising on battery longevity and compatibility with magnetic resonance imaging (MRI) ABBOTT PARK, IL (STL.News) Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's next-generation Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The devices bring new benefits to patients with heart rh...

Business

Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19

Significant Test Manufacturing Capacity, Large Installed Base of Automated Instruments Yield Testing Breakthrough MARLBOROUGH, MA (STL.News) Hologic, Inc. (Nasdaq: HOLX) announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay to detect the novel coronavirus. The newly authorized test runs on Hologic’s fully automated Panther® system, more than 1,000 of which are already installed in clinical laboratories throughout the United States. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic has begun distributing its new coronavirus test, and expects to produce an average of one million tests per week. Comb...

Business

FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options THOUSAND OAKS, CA (STL.News) Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator, also known as a cardiac myotrope,1 being developed for the potential treatment of chronic heart failure with reduced ejection fraction (HFrEF). Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need for such a disease or condition. "This Fast Track designation represents an impo...

Health

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market Agency Continues to Target the Sale of Unauthorized, Flavored E-cigarette Products That Appeal to Youth Silver Spring, MD (STL.News) Today, the U.S. Food and Drug Administration issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game syste...

Health

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision

Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems Silver Spring, MD (STL.News) Today, the 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 Emerg...

Health

FDA on Signing of the COVID-19 Emergency Relief Bill

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation Silver Spring, MD (STL.News) The US Food & Drug Administration released the following statement: On Friday, the President signed into law a $2 trillion emergency relief bill that will continue to aid the response efforts and ease the economic impact of COVID-19. The legislation will help all of us at the FDA deliver support and guidance to protect and promote public health during this unprecedented pandemic. Specifcially, the legislation provided an additional $80 million in funding to continue the Agency’s COVID-19 response efforts, including the development of medical countermeasures and vaccines, promoting the advanced manufacturing of medical products an...

Health

US Food and Drug Administration Approves ZEPOSIA for Multiple Sclerosis

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis In clinical trials, ZEPOSIA demonstrated efficacy on a key clinical marker of disease activity – annualized relapse rate (ARR) – as compared to AVONEX ® (interferon beta-1a) ZEPOSIA is a sphingosine-1-phosphate (S1P) receptor modulator that requires no label-based first dose observation 1 ZEPOSIA adds to Bristol Myers Squibb’s legacy immunology franchise and marks the first FDA-approved New Drug Application since the Celgene acquisition PRINCETON, NJ (STL.News) Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsin...

Business

FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

WALTHAM, MA (STL.News) PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit to detect SARS-CoV-2, the virus that causes COVID-19. PerkinElmer’s RT-PCR test is marketed as an in vitro diagnostic (IVD) device by meeting the requirements of the European In Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide. “Despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this glo...

Business

Abbott Receives FDA Emergency Use of Authorization & Launches Test for Coronavirus

- The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S. - Abbott shipping 150,000 laboratory tests immediately; tests already sent to hospital and academic medical center labs in 18 states including Illinois, California, New York, Massachusetts and Washington - Company scaling up production at its U.S. manufacturing location to reach capacity for 1 million tests per week by end of March ABBOTT PARK, IL (STL.News) Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the company's molecular test for novel coronavirus (COVID-19). Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the ...

Health

Kettle Cuisine Midco, LLC, Recalls Ready-To-Eat Soup Products due to Misbranding and Undeclared Allergens

WASHINGTON, DC (STL.News) Kettle Cuisine Midco, LLC, a Lynn, Mass. establishment, is recalling approximately 200 pounds of ready-to-eat (RTE) lentil and beef soup products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain egg and wheat, known allergens, which are not declared on the product label. The RTE lentil and beef soup items were produced on Dec. 12, 2019. The following product is subject to recall: [View Labels (PDF Only)] 7-oz. polypropylene cup with film containing “little dish FRESH FOOD FOR KIDS Lentils & Beef with Vegetables for toddlers” with a best buy date of 1/10/20. The products subject to recall bear establishment number “EST.18468” inside the USDA mar...

Health

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Silver Spring, MD (STL.News) The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer). “The FDA is committed to ensuring that the medicines Americans take are safe and effective. We began testing ranitidine products immediately after we learned of the potential impurity. When we identify lapses in the quality of drugs that pose potential risks for patients, the FDA makes all efforts to understand ...