TORONTO, Aug. 27 /CNW/ - IntelliPharmaCeutics Ltd. (Delaware) is pleased
to announce that its operating company IntelliPharmaCeutics Corp. of Toronto
has received a letter from the Food and Drug Administration (FDA) of the
United States indicating that its abbreviated new drug application (ANDA)
submitted pursuant to Section 505(j) of the Federal Food, Drug and Cosmetic
Act with the FDA for approval to sell a certain drug product commercially in
the United States was accepted for filing as of the filing date of May 14,
The drug product in question is one being developed for commercialization
in the United States in accordance with a drug development agreement with a
development partner. The drug product uses IntelliPharmaCeutics' proprietary
controlled release drug delivery technology, and is a generic (ANDA) of a
branded drug now sold in the United States.
The application will now proceed to full review by the FDA, a process
which could take from 12 to 36 months depending on normal FDA review
procedures and possible standard patent challenges by the owner of the branded
drug in question.
This accepted filing is a very significant step in the business of the
Company and as an active participant in the field of the commercialization of
high-technology drug products.
Dr. Isa Odidi, Co-Chief Scientific Officer of the Company stated: "We are
very pleased with the recognition that this acceptance of the filing of this
drug application gives the Company and our scientific team."
The Company and its development partner will pursue this application
diligently. The Company will also continue to diligently pursue its active
pipeline of 9 generic ANDA's drug candidates and one new drug (NDA) drug
For further information:
For further information: Isa Odidi, Chief Executive Officer and Co-Chief
Scientific Officer, IntelliPharmaCeutics Corp., 30 Worcester Road, Toronto,
Ontario, M9W 5X2, Tel: (416) 798-3001, Fax: (416) 798-4276