FDA Permits Production Of Generic Heroin Drug Against Bid Of ReckittMain Category: Regulatory Affairs / Drug Approvals
Also Included In: Alcohol / Addiction / Illegal Drugs | Pharma Industry / Biotech Industry
Article Date: 26 Feb 2013
Two generic forms of Reckitt Benckiser's heroin addiction medication have been approved by U.S. regulators, rejecting the company's bid to prevent rival products based on their belief that stricter regulations were needed on packages to better protect children.
Reckitt Benckiser, a British consumer health products company, makes a good portion of its earnings from Suboxone, a medication that has buprenorphine and helps people who are addicted to opiates deal with withdrawal symptoms when they quit.
Reckitt has been aware about the possibility of generic rivals starting in the market place since its exclusivity status timed out in 2009.
Attempting to persuade the U.S. Food and Drug Administration (FDA) to say no to applications from other businesses, Reckitt petitioned for outside manufacturers to adopt strict packaging guidelines before being accepted.
However, Reckitt has now been informed by the FDA that two forms of generic Suboxone medications have now been approved in the U.S.
Additionally, the FDA noted in its announcement that it had gotten comments that Reckitt's stance was believed to be an "anti-competitive practice" and that the company will now be referred to the Federal Trade Commission.
In 2012, Reckitt ended the sale of Suboxone tablets in the U.S. and replaced them with individually closed film versions that can melt on the tongue, claiming that there was an elevated risk of kids obtaining the tablets accidentally. the Suboxone sublingual film was approved by the FDA in September 2010.
The FDA concluded there was not enough evidence to verify the claim that the tablets needed stricter packaging. The report said:
"While FDA welcomes and encourages sponsors to utilize unit-dose packing for their oral buprenorphine products, we do not believe the data at this time support refusing to approve applications that lack such packaging."
A descending trend in accidental exposure of kids to the medication could be caused by many factors, such as a better understanding by patients and pharmacists of the harms of an overdose, and simpler labeling.
Reckitt's DisappointmentReckitt has said in an annoucement that they are disappointed with the decision, however, they plan on working with the FDA on safety improvements.
They note that they are committed to high standards of safety, specifically for child resistant, unite-dose packaging for burprenorphine-based treatment products for opioid addiction.
However the regulator concluded:
"The timing of Reckitt's September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for this product was expected to begin, cannot be ignored."
Written by Kelly Fitzgerald
Copyright: MediLexicon International Ltd
Original article posted on Medical News Today.
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