: ' FDA'

Generic Opana Painkiller Coming to U.S.

By Richard Lenti Generic versions of the widely abused painkiller Opana are set to hit the U.S. market at the start of the New Year after drug maker Endo Health Solutions Inc. (NASDAQ: ENDP) lost its [...]

Analyst: Zohydro Could Still Win FDA Approval

Zohydro, a new opioid painkiller developed by San Diego-based Zogenix (NASDAQ: ZGNX), could still be approved by the Food and Drug Administration to treat chronic pain, even though an advisory panel voted against it, according to [...]

FDA Panel Rejects New Painkiller Zohydro

A government panel of pain experts has advised the Food and Drug Administration to reject Zohydro, a new and stronger version of hydrocodone, because of potential abuse of the painkiller. The vote was 11-2 with one [...]

FDA Inspectors Find Mold, Bacteria and Bugs at Ameridose

The Food and Drug Administration has released a scathing report on poor sanitary conditions and a lack of quality control at Ameridose, the sister company of the Massachusetts compounding pharmacy linked to a deadly outbreak of [...]

Living with Pain: Wrong People Being Targeted in the War on Drugs

Readers who’ve followed this column know that I primarily focus on the collateral damage the war on drugs inflicts on physicians and pain patients. I see this damage as lethal to the practice of physicians who [...]

FDA Approves New Rheumatoid Arthritis Drug

The Food and Drug Administration has approved an expensive new drug to treat adults with moderate to severe rheumatoid arthritis, even though the agency has not fully evaluated its safety and wants further testing.  A one [...]

FDA: Ameridose Recall Could Worsen Shortage of Six Life-Saving Drugs

The Food and Drug Administration has identified six life-saving injectable drugs already in short supply that may be even harder to get because of the recall of all Ameridose products. The drugs, which are on the [...]

Drug Shortages Feared as FDA Announces Second Recall in Meningitis Outbreak

The sister company of the Massachusetts pharmacy linked to a deadly outbreak of fungal meningitis is voluntarily recalling all of its drug products, including many pain medications . The recall was announced after the Food and [...]

FDA Under Fire for Meningitis Outbreak

As the death toll continues to rise in the nation’s fungal meningitis outbreak , the Food and Drug Administration is coming under fire for its handling of the public health crisis. The consumer group Public Citizen [...]

Pharmacy Linked to Meningitis Outbreak Sold Drugs to Hundreds of Hospitals and Clinics

Over a thousand hospitals, pain clinics, cosmetic surgery centers, eye clinics and other health care providers received drugs from a Massachusetts pharmacy linked to a deadly meningitis outbreak that has taken the lives of 23 people [...]