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Pain drugs

Latest Headlines

Latest Headlines

Under fire, FDA chief Hamburg defends approval of pain pill Zohydro

As pharmacies began dispensing Zogenix's powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.

State AGs lobby FDA to reconsider nod for powerful Zogenix painkiller

The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.

FDA ratchets up requirements on long-acting, extended-release opioids

The FDA, under pressure to help curb abuse of opioid painkillers, has taken yet another step to dampen their use. The agency said today that it is "invoking its authority" to require that long-acting and extended release drugs should only be used for severe pain and only when other measures don't work.

Mallinckrodt tamper-resistant drug performs well for bunion patients

Mallinckrodt's treatment will offer a level of resistance to tampering with the highly addictive product, a quality that could set it apart in the competitive pain drug arena.

As Sativex takes on Europe bit by bit, GW Pharma works on FDA

GW Pharmaceuticals is taking another chance at the FDA. The company is working on a new application for approval of Sativex, the cannabinoid drug now sold in Canada and Europe to treat spasticity in multiple sclerosis patients.

J&J slapped with HHS subpoena on Nucynta marketing

Issued by the Department of Health and Human Services' inspector general, the subpoena is looking for documents and information about sales, marketing and promotional activities on two formulations of Nucynta, an opioid pain reliever. 

Actavis to make generic tamper-resistant OxyContin

Purdue Pharma and generic drugmaker Actavis have settled their patent suit over a special formulation of the painkiller OxyContin just 10 days the FDA banned generic versions that do not carry abuse resistant technology.

FDA halts generic OxyContin, handing Purdue a victory

For months FDA regulators have been wrestling with the dangers of allowing a flood of cheap, generic version of the highly addictive OxyContin on the market vs. consumers with pain issues having access to cheaper meds.

Panel vote will add to FDA pain drug puzzle

The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.

FDA backs tech to throw off painkiller addicts

At the very moment on Wednesday that the FDA released its draft guidance for makers of tamper-resistant prescription painkillers, Harald Stock, CEO of Grünenthal Group, was explaining why the agency should require such protection from all opioids. The German company specializes in tamper-resistant pain products.