Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.
The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.
Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.
The governor of North Dakota has signed into law a bill that would require pharmacy benefit managers to inform pharmacies about how reimbursement for generic prescription drugs is calculated under maximum allowable cost benchmarks and provide a more detailed appeals process to pharmacies to contest the MAC reimbursement caps that PBMs set up.
The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.
An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.