Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Let FDA's Dr. Woodcock explain it to you...

Weasel.....you seem to be the only one confused on Wims post. he stated the company clarified they dont need to name the manufacturer and could still receive a tentative approval, but they need to name a manufacturer to receive a final approval.

http://www.fda.gov/Drugs/NewsEvents/ucm322399.htm

October 3: Can you explain what is meant by tentative approval?



Answered by CDER's Director Dr. Janet Woodcock

If a generic drug product application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product, FDA issues a tentative approval letter to the applicant. The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A product that has tentative approval cannot be marketed or sold in the United States.

So, according to you, IPCI "clarified" that the manufacturer only needs to be named prior to Full Approval by telling us that a Tentative Approval does not require a manufacturer. Okay. I forgot they speak Canadian. I'd be interested to hear about some other examples of companies you know of with pending NDA applications who are talking about what they need to do (or not do) in order for their application to receive Tentative Approval.


IPCI is now using "Tentative Approval" language for a reason. I recommend you figure out that reason.




http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022272&Appl_type=N