On 1/7, Endo Pharmaceuticals Holdings ENDP announced that the FDA issued a complete response letter (CRL) for the tamper resistant formulation of Opana ER, Oppenheimer reports.
“We anticipate ENDP will respond to the CRL by mid-2011, with possible approval by 2012, given a six month review cycle,” Oppenheimer writes. “Importantly, we do not anticipate meaningful generic switching prior to approval of Opana TRF in 2012. We believe the Opana franchise remains intact and are maintaining our current estimates.”
Oppenheimer said that it views this complete response letter as a temporary setback for the Opana franchise and continues to expect eventual approval of Opana TRF.
“As such, we maintain our current estimates and reiterate our Outperform rating and $42 PT,” Oppenheimer adds.
Endo Pharmaceuticals closed Friday at $35.11.
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Posted In: Analyst Ratingsendo pharmaceuticalsHealth CareLife Sciences Tools & ServicesOppenheimerPharmaceuticals
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