Zohydro ER Faces FDA Rejection

.

Zohydro ER Faces FDA Rejection

The Food and Drug Administration (FDA) is now opposing the Zohydro ER made by Zogenix Inc. which is stronger and new version of hydrocodone.

The drug was voted very low i. e. 11-2 with one nonparticipation. FDA received the suggestion of government pain expert panel over their rejection since the painkiller was reported to cause high levels of abuse.

Zogenix Inc. is based San Diego who developed the Zohyro ER capsules to cure average to chronic pains. The rejection has emerged as a vital setback for the drug maker since the trades of the drug have been stopped in wake of the news.

However, the FDA will make a final decision about the drug in March 2013 when it will tell whether the drug is safe for use. And if the drug gets the nod from the health officials, US will get its first pure hydrocodone painkiller while those in market as of now are of lower strength.

"There is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER", said Stephen Farr, the President and Chief Operating Officer of Zogenix.

The drugs with hyrocodone and other combinations come under Schedule III drugs while Zohydro ER shall be classified as schedule II drug as it is more powerful.


Latest News

Springdale, the Small Utah town Finally Repeals Chain Restaurant Ban After a Dec
Oshkosh Corporation Won a $30billion Contract for Replacing Humvee Units of the
Federal Reserve Vice Chairman Fischer Hints Inflation is Likely to Rebound Permi
Trib Total Media Plans to Sell Nine Newspapers including Four Daily and Five Wee
Twitter Plans to Employ More Women Next Year to Diversify Its Workforce
OPEC Oil Producers Prepared to Endure Lower Oil Prices But will Continue their P
Stanley Fischer Federal Reserve Vice Chairman Says No Decision Has Been Taken fo
Biggest Daily Climb Noted in the Oil Markets in Past Six Years
According to Sources Marchionne to Take over as Both CEO and Chairman of Ferrari
Consumer Spending and Inflation Drops in Japan Adding Pressure on Policymakers
Patterson Companies, Inc reports $29.7 million First Quarter Profit
Gap Announced by Beginning of Next year It will Phase Out On-Call Scheduling