Actavis resumes manufacturing of oxycodone
This article was originally published in The Gold Sheet
Actavis Totowa said FDA gave it approval to resume production of painkiller oxycodone 15 mg and 30 mg tablets at its Little Falls, N.J., facility following an agency inspection. The reopening will help ease a shortage of oxycodone that followed various FDA enforcement actions, including one that led Actavis last August to recall oxycodone and 65 other products made at its Little Falls plant, which shut down after FDA found numerous GMP violations. A Dec. 29 FDA consent decree set conditions for resuming production at Little Falls and two Totowa, N.J., facilities. "Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," said Nasrat Hakim, vice president of quality compliance and technical services for Actavis
You may also be interested in...
The US FDA and NIST have agreed to help industry modernize and update pharmaceutical manufacturing methods and to improve supply chain resilience.
Medtronic is sponsoring a trial to evaluate its adaptive deep brain stimulation technology, a unique feature of the Percept PC device for treating Parkinson’s disease.
The company cited lackluster efficacy in its decision to discontinue development of V590 and V591. It will instead develop two drugs to treat COVID-19.