poltcompany.blogg.se

Fda request endo pharmaceuticals
Fda request endo pharmaceuticals








fda request endo pharmaceuticals

The request from the FDA to remove Opana from the market marked the first time the federal regulatory watchdog urged a company to remove an opioid due to concerns of abuse.Įndo’s Opana ER won FDA approval in 2006 for the management of moderate-to-severe pain. “To the contrary, Endo remains confident in the clinical research and other data demonstrating Opana ER’s safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.” “Endo reiterates that neither the FDA’s withdrawal request nor Endo’s decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed,” the company wrote in a statement. The company stands by the safety and efficacy of its pain-relief product. Opana brought in $158.9 million in net sales in 2016. To write off the remaining net book value of the product, Endo said it expects to incur a pre-tax impairment charge of $20 million in the 2nd quarter of this year. The move comes just weeks after the FDA asked the company to pull the plug on its opioid, arguing that the benefits of the abuse-deterrent drug no longer outweigh the risks. Endo Pharmaceuticals (NSDQ: ENDP) said today that it will voluntarily pull its Opana ER painkiller from the market.










Fda request endo pharmaceuticals