The FDA continues to pressure manufacturers and distributors for selling products with undeclared sildenafil and tadalafil. The agency recently announced that Wilmington Delaware–based Ultra Supplement LLC is voluntarily recalling lot number DAP272109 of Sustango capsules over the presence of tadalafil (Cialis). The company markets the product as a supplement for men. Sustango was available for…
Expert answers to nitrosamine impurity questions
The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant –…
Cardinal Health announces $124M settlement of investors’ opioid suit
Cardinal Health directors’ insurers will pay the company $124 million to settle a stockholder derivative action related to the opioid crisis. The company (NYSE: CAH) on July 22 issued a court-authorized notice to alert investors to a settlement hearing to be held on Oct. 4 in U.S. District Court in Southern Ohio. If the settlement…
FDA warns four companies over selling honey tainted with prescription drugs
FDA has sent warning letters to four companies for illegally marketing honey-based products with unlisted active drug ingredients found in the erectile dysfunction drugs Cialis (tadalafil) and Viagra (sildenafil). The agency said it confirmed the presence of contaminants in the products through laboratory testing. The agency sent the warning letters to the following companies: Thirstyrun…
HHS and DOD order 3 million doses of Novavax COVID-19 vaccine
Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC. The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.…
FDA prevented 317 drug shortages in 2021
FDA worked with pharma companies to avert a record number of drug shortages in 2021 based on a recent report to Congress that tracked data starting in 2012 when the FDA Safety and Innovation Act (FDASIA) was passed. In 2021, 115 manufacturers notified the FDA of 777 potential drug and biologic shortages. Ultimately, the agency worked to…
Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data support a three-dose primary series of their COVID-19 vaccine in young children. Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial in young children evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong…
FDA curtails use of Janssen COVID-19 vaccine over blood clotting concerns
The FDA has decided to limit the use of the COVID-19 vaccine to individuals at least 18 years old who cannot receive other authorized or approved COVID-19 vaccines. The agency also will authorize its use for individuals who would “otherwise not receive a COVID-19 vaccine.” FDA came to the conclusion after reviewing data related to…
FDA sends warning letters to CBD and delta-8 THC product vendors
The FDA has issued warning letters to several companies selling products with cannabidiol (CBD) and delta-8 tetrahydrocannabinol (delta-8 THC) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). While the agency has previously sent out warnings to firms selling CBD-related products from 2015 to 2022, it is the first time it has sent…
Pfizer recalls certain lots of blood-pressure drug Accupril
Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril. Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure. N-nitroso-quinapril, which can be frequently found in…