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TORONTO, March 13, 2013 (GLOBE NEWSWIRE) --
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced an update on its generic versions of the marketed drugs Keppra XR® and Pristiq®.
In September of 2012, the Company announced that it had filed with the U.S. Food and Drug Administration ("
FDA") two Abbreviated New Drug Applications ("
ANDAs"), for generic versions of the marketed drugs Keppra XR® (levetiracetam extended-release tablets), an antiepileptic product for the treatment of partial onset seizures in patients with epilepsy and Pristiq® (desvenlafaxine extended-release tablets), a product for the treatment of depression.
We are pleased to announce that the FDA has accepted for filing the Company's ANDA for generic Keppra XR®.
Based on the FDA's preliminary review and comments on the Company's ANDA for generic Pristiq®, the Company plans to repeat one of three bioequivalence studies for the product candidate. The Company will amend its existing application for generic Pristiq® to include the new study upon its successful completion.
7 ANDAs in total have now been accepted by the FDA for review. The Company is proceeding with development of all its product candidates, including several other ANDA and New Drug Application ("
NDA") product candidates that have been previously disclosed and described by the Company.
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. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including filings with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.