Related Content
- New alliance will crack down on adulterated products touting dietary supplement claims
- FDA approves Novartis drug for high blood pressure treatment
- FDA releases annual 'Generic Drug Roundup'
- Sandoz introduces generic Zosyn
- FDA approves Amneal generic for treatment of hypertension and liver cirrhosis
NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.
The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.
The FDA issues a complete response letter when it has finished reviewing a regulatory application for a drug, but remaining questions preclude final approval.
