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

Rise in Russian Arms Sales In spite of a Drop Globally
PetSmart Sells itself with an $8.3Billion Deal
Falling Oil Prices Result in a Drop in Stocks
Shares of Amaya Fall Due to Probe Conducted by Securities Regulators
Americans Consumers Display Confidence In the Market with Gain in Sales
It’s Time to Hurry Up to Enrol in the First Phase of Affordable Care Act Health
After Merger with Alliance Boots,	Walgreen CEO will Retire
Falling Fuel Prices Lift Airline Profits But No Respite in Fares Expected
Citigroup to Pay Likely $2.7B as Legal Charge
Michael Jeffries Retires as the CEO of Abercrombie & Fitch
Deutsche Bank in Trouble Again in the U.S. for Alleged Tax Scheme
Popular Demand Brings French Toast Crunch Back on the Shelves