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This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market.
The inspection was conducted in June 2024. The warning letter summarized significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Among the findings, data integrity was cited in the letter, which is a recurrent theme within FDA inspection of the Pharmaceutical industry in India. [27]
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. [1] India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports.
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry at some time in their existence, provided they were engaged in the production of human (as opposed to veterinary) therapeutics.
An FDA director who oversaw the approval of OxyContin got a $400K gig at Purdue Pharma a year later. A new book by Patrick Radden Keefe reported on these claims and on the billionaire Sackler family.
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.
(Reuters) -The U.S. Food and Drug Administration has granted approval to a treatment from Verona Pharma for a chronic lung disease that commonly affects smokers, the U.K.-based company said on ...