US Regulators Deny Manufacture Of Generic OxyContin

The announcement was made Tuesday by US health regulators for the Food and Drug Administration, stating they will not approve any type of generic version from the original form of OxyContin, a widely abused prescription painkiller.

The decision was made the day the patent for the original formulation of OxyContin was set to expire, otherwise allowing competitive companies to manufacture less expensive, generic versions of the drug.

Oxycodone hydrochloride is the chemical name of the drug sold under the brand name OxyContin. Without competition, the price of the painkiller is not likely to decrease, upsetting patients who may require the pricey medication.

The motive behind the decision is primarily because the original formula of the painkiller can be crushed into powder and snorted to produce a quick high. Crushing hurdles the time-release composition of the medication as OxyContin is meant to gradually alleviate pain over a 12-hour period on average.

As such, the FDA did approve measures to reformulate and re-label OxyContin in 2010, ordering the medication’s physical and chemical properties be altered in such a way as to make crushing and snorting – abusing the drug – more difficult. Instead of pills being easily milled into a fine powder, they become something of a viscous sludge.

In the event generic versions are eventually approved, they too would have to be formulated to deter abuse. For now, the manufacturer Purdue Pharma will be the only producer of OxyContin. For reasons of safety, the FDA has the right to refuse applications for generic oxycodone hydrochloride.

Officials find this motion of refusing generic imitators will reduce the number of oxycodone abuse and overdoses, as deaths linked to painkiller use has been on the rise, according to CDC reports. The figures reflect the increase has been largely propelled by the abuse of prescription painkillers such as OxyContin and Vicodin. Drugs overdose overtook traffic accidents as a cause of death in the US in 2009 and have continued to escalate.

In hopes of combating the abuse of prescription painkillers, the FDA has also considered a proposal to limit the availability of daily doses, restricting their use to 90 days or less for non-cancer patients – using computer drug monitoring to keep track of prescribed amounts.

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