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Intellipharmaceutics International Inc V.IPCI.H

Alternate Symbol(s):  IPCIQ

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to a range of existing and new pharmaceuticals. It has developed several drug delivery systems based on this technology platform, with a pipeline of products in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company’s abuse-deterrent oxycodone hydrochloride extended-release formulation (Oxycodone ER) based on its proprietary nPODDDS novel Point of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin XR (pregabalin extended-release capsules). Its product portfolio includes both new products and controlled-release generic products.


TSXV:IPCI.H - Post by User

Post by Rorschached99on May 03, 2011 12:59pm
283 Views
Post# 18523307

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.






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