FDA deal allows Amarin to promote drug for off-label use
New York
IN a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.
The agreement settles a legal case between the agency and the company, Amarin, a small drugmaker that sued the FDA last year for the right to promote its only product, Vascepa, to a broader range of patients. In August, a federal district judge in Manhattan ruled that the FDA could not prohibit Amarin from using truthful information to promote its drug, even for unapproved uses, because doing so would violate the company's right to free speech.
BT is now on Telegram!
For daily updates on weekdays and specially selected content for the weekend. Subscribe to t.me/BizTimes
Consumer & Healthcare
‘Extreme’ climate blamed for world’s worst wine harvest in 62 years
Sheng Siong Q1 net profit up 9.3% on higher revenue
Nestle sales growth sputters on US slump, vitamin snags
Hermes Q1 sales jump 17% on strong China demand
Cordlife’s independent auditor to retire after issuing disclaimer of opinion on FY2023 financials
Cutting the cord?: Events leading up to Cordlife’s MOH suspension and arrests of its directors, ex-group CEO