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ANDA Review Times

 

 

www.custopharm.com

There is a growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”).  The median ANDA approval time in Fiscal Year 2009 was 26.70 months.  This is up from 21.65 months in Fiscal Year 2008 and up from 17.3 months in Fiscal Year 2003.  Today, the ANDA backlog has surpassed the 2,000 application mark and is reportedly growing at about 100 applications per month. We understand that the median ANDA approval time is edging closer to 

30 months from application submission.

Companies must submit ‘well written’ regulatory filings.  There is so much effort in compressing development timelines, it is critical to file the most efficient ANDA/NDA/IND possible to compress review times.

If you are

 not filing ‘well written’ regulatory filings it is costing your company time and money.  We have countless examples of how the ‘well written’ Gateway filing improves approval timelines.  

The above statistics are the building blocks to file a superior filing to the FDA, we continually implement what we learn to build a stronger A

NDA/NDA/IND.  When Custopharm fully develops a product there are fewer review cycles with the FDA, each review cycle can cost months of ‘on the market’ time.  Custopharm understands the technical aspect of development.

-Custopharm has filed many IND’s for development companies.

-Custopharm filed the first eCTD ANDA in 2004

-Custopharm

 has filed over 90 eCTD ANDA’s

-Custopharm w

as approved for the Electronic Submission Gateway in May 2008, filed over 475 since.

-Custopharm has filed 159 Gateway filings in 2009

-Filed 100+ Gateway filings through May 15th, 2010

-In 2009 Custopharm responded to over 100 deficiencies

Trust your Regulatory filings to Custopharm, a 'well written' ANDA has become more important


 than an efficient development timeline.  More time on the market means more profit in your bottom line. 

 

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