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SoviHep is the first sofosbuvir brand launched in India by Zydus in the year 2015. [4] In 2019, injectable ketorolac tromethamine manufactured by Zydus (Cadila Healthcare) was recalled due to microbial growth. [13] In 2020, Zydus Cadila's drug Desidustat received approval by the USFDA to initiate clinical trials on cancer patients. [14]
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
India's Zydus Lifesciences is aiming to launch its first new drug in the United States by early 2026, looking to tap into the multi-billion dollar market for treating a type of liver disease ...
The recall covers over 112,000 bottles distributed nationwide. Skip to main content. Sign in. Mail. 24/7 Help. For premium support please call: 800-290-4726 more ...
These changes caused drugs made with tetrazole to be contaminated with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which cause genetic damage and cancer. [20] This contamination was not detected until 2018. The incident, according to medicinal chemist and pharmaceutical industry blogger Dr. Derek Lowe, points to a greater ...
Pfizer recalled certain lots of its high blood pressure medication for containing high levels of nitrosamines, which can lead to increased cancer risk. Pfizer recalls some high blood pressure ...
In medicine, tromethamine is occasionally used as a drug, given in intensive care for its properties as a buffer for the treatment of severe metabolic acidosis in specific circumstances. [ 4 ] [ 5 ] Some medications are formulated as the "tromethamine salt" including Hemabate ( carboprost as trometamol salt), and " ketorolac trometamol". [ 6 ]