> Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker denied the request. Now, the U.S. regulator is applying more pressure.
> The FDA’s Center for Drug Evaluation and Research (CDER) has proposed to withdraw the approval of Amgen's oral medicine, saying that new information indicates that data was "manipulated" to facilitate its green light.
> The FDA said that Amgen’s options are to pull the drug from the market or request a hearing.
> The company is evaluating its next steps, an Amgen spokesperson said in an email.
randycupertino•1h ago
> The FDA’s Center for Drug Evaluation and Research (CDER) has proposed to withdraw the approval of Amgen's oral medicine, saying that new information indicates that data was "manipulated" to facilitate its green light.
> The FDA said that Amgen’s options are to pull the drug from the market or request a hearing.
> The company is evaluating its next steps, an Amgen spokesperson said in an email.
Full CDER letter here: https://www.fda.gov/media/192160/download?attachment