TSXV:IPCI.H - Post by User
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Rorschached99on May 03, 2011 12:59pm
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GOOD NEWS TODAY
GOOD NEWS TODAYBelow, today's press release. Nirvana any day now!
IntelliPharmaCeutics gets acceptance for ANDA filing
2011-05-03 08:02 ET - News Release
Dr. Isa Odidi reports
FDA ACCEPTS FOR FILING INTELLIPHARMACEUTICS' ANDA FOR GENERIC SEROQUEL XR(R)
TheU.S. Food and Drug Administration has accepted for filingIntellipharmaCeutics International Inc.'s abbreviated new drugapplication (ANDA) for a generic version of Seroquel XR (quetiapinefumarate extended-release tablets). Seroquel XR is an oral psychotropicagent indicated for the treatment of schizophrenia, bipolar disorder andmajor depressive disorder. Sales of Seroquel XR in the United Stateswere approximately $823-million in 2010.
"We were very pleased with the FDA's acceptance of our filing for ageneric of Seroquel extended-release capsules," commented Dr. Isa Odidi,chief executive officer of IntellipharmaCeutics. "I believe this speaksto the quality of our application and the work that is being performedat IntellipharmaCeutics."
IntellipharmaCeutics has five ANDAs awaiting FDA approval. The companydevelops both ANDA product candidates and new drugs through the new drugapplication (NDA) 505(b)(2) regulatory pathway.
We seek Safe Harbor.