Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem. The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage. Radiologists use contrast agents…

In Q2 2022, the number of recalled units in the U.S. pharma industry dropped sharply. In the first quarter of the year, drug makers recalled more than 435 million units. However, the number of recalled units in Q2 2022 was 20.5 million, according to the Sedgwick Brand Protection Q2 2022 recall index. “It was definitely a…

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…

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 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 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…

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 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 (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…

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…