Endo Pharmaceuticals has announced
that the FDA has granted final approval for the company's new drug applications
(NDAs) for its extended-release and immediate-release formulations of oxymorphone
hydrochloride. These products are now known under the trade names Opana ER tablets
and Opana tablets.
Opana ER is indicated for the relief of moderate-to-severe
pain in patients requiring continuous, around-the-clock opioid treatment for an
extended period of time. This is the first time oxymorphone will be available
in an oral, extended-release formulation. Opana ER will be available in 5 mg,
10 mg, 20 mg and 40 mg tablets. Opana (the immediate-release version) is indicated
for the relief of moderate-to-severe acute pain where the use of an opioid is
appropriate and will be available in 5mg and 10mg tablets.
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Procleix’s Zika Assay Earns FDA Approval for Use With Panther System
The assay is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products.
FDA Plans Study of Risk Information in Direct-to-Consumer Print Ads
The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each.