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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.
Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs. [21] 2022–2023 United States P. aeruginosa outbreak in eye drops
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 ...
A CVS spokesperson told Fortune its recalled store-brand over-the-counter products make up fewer than 1% of the FDA’s drug recalls in the past 10 years. It also completes an average of 350 daily ...
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]
The risk of developing both of these conditions while taking a GLP-1 receptor agonist medication is low. But research has generally shown that the risk of developing pancreatitis while taking this ...
In December 2016, Zydus Discovery DMCC, a research subsidiary Zydus Lifesciences, was cited by the US FDA for deliberately misbranding saroglitazar. In a December 21, 2016, letter to the company, the US FDA asked it to stop using broad statements, such as the "world's first" and to stop suggesting that the drug is approved throughout the world ...