FDA Approves First Generic Of Daraprim
Brand Price Had Been Hiked 4,000% By Martin Shkreli
Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.
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Dr Reddy’s has launched the first generic version of Daraprim in the US. The company has also introduced naloxone with 180 days of exclusivity under the FDA’s Competitive Generic Therapy pathway, as well as the first US generic of ziprasidone mesylate.
In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.
Excerpts from more than 300,000 documents, including emails, from Turing Pharmaceuticals Inc. and Valeant Pharmaceuticals International Inc. painted a picture that's anything but pretty about how those firms went about buying older drugs and jacking up their prices – with the now-former head of one of those companies, Martin Shkreli, declaring "$1bn here we come."