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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Other companies have largely halted practices at issue in the ‘diabolical anticompetitive plan’ undertaken by Shkreli’s former firm. FTC did not challenge the price hike for Daraprim itself, but did cite an effort to block release of sales data and other tactics to discourage generics.
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.