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July 31, 2011

Comments

Dear Sir,
This is regarding Abbot & Hospira on Paricalcitol. as mentioned here, If Hospira filed NDA (505(b)(2) does it come under PIV filing?. What is the difference between Hopira's 505 (b)(2) application and Abbot's already aprroved NDA?

Dear Reddy B:

NDAs under 505(b)(2) are similar to ANDA filings in many ways - they offer the option for a generic company to rely on data provided by the innovator to obtain FDA approval to market their product. And just like an ANDA filing, the generic filer must submit a certification - such as was done here, where Hospiral submitted a Para IV certification. The differences between an NDA under 505(b)(2) (also known as a "paper NDA") and an ANDA is that a 505(b)(2) NDA allows for certain differences between the generic product for which approval is sought and the approved innovator product - for example, changes in formulation, changes in dosage stregth, etc. So here, Abbott filed the original innovator NDA, and Hospira's NDA is one of a generic that will rely in part on Abbott's NDA to obtain FDA approval.

I hope this helps.

Sherri

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