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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]
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.
The US FDA is able to extend the shelf life of drugs throughout national, state, local, tribal, and territorial stockpiles through two legal means: by issuing an Emergency Use Authorization on using a drug past its expiration date (which is legally an unapproved use of a drug), or by a "expiration dating extension authority" established by the ...
The onslaught of food recalls — listeria in 12 million pounds of meat, E. coli in McDonald’s Quarter Pounders, and many others — has been hard to ignore lately, ...
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 ...
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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 ]
The U.S. government's auto safety regulator has ended a 2 1/2-year investigation into Ford engine failures after the company replaced engines or extended the warranty on some vehicles. The ...