Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.
Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.
But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement.
More: The opioid crisis hits home. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".
"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.
Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.
The pills contain sufentanil, a chemical cousin of the opioid fentanyl. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.
The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
Don't miss the Spice Girls live on Heart Breakfast
The singer giggled at her admission, but the official website states the tickets will actually be going on sale on Saturday. The Spice Girls - minus Victoria Beckham - announced the initial six United Kingdom stadium dates on Monday.
USA mail bomb suspect agrees to be held without bail
Cesar Sayoc, who was transferred from federal custody in Florida, hugged his lawyer after a hearing in which Assistant U.S. Kamala Harris, D-Calif., former CIA Director John Brennan and former Director of National Intelligence James Clapper.
Dead Republican brothel owner Dennis Hof wins election in Nevada
This year, he ran as a Republican and earned backing from former Trump advisor Roger Stone and tax-cut activist Grover Norquist . Hof, a reality TV star of the HBO show " Cathouse ", died last month at the age of 72 after a weekend celebrating his birthday.
Rafael Nadal ruled out of London event — ATP Finals
However, despite his achievements, Djokovic appears doomed never to be held in the same warm esteem as Federer and Nadal . By virtue of Nadal's withdrawal, Novak Djokovic has mathematically clinched the year-end No. 1 ranking.
Nine members of family killed in Sicily flooding
His wife, two other children, his parents, brother, and sister, his nephew and the boy's grandmother all died, he said. Northern Italy was battered by other storms earlier in the week, killing at least 15 people.
States Legalize Marijuana For Recreational Or Medical Use
In Missouri, voters will be asked to chose between three separate proposals legalizing medical marijuana to varying degrees. To learn more about the proposal and the effects of legalizing marijuana, read Mark Peterson's in-depth report .