
Home » ENDO SUBMITS NDAS FOR OPANA TREATMENTS
ENDO SUBMITS NDAS FOR OPANA TREATMENTS
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.
KEYWORDS Drug Pipeline Alert
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