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Blog & Resources Camargo Blog DESI Drug

The Camargo Blog

Get insight and information from our team of experts to improve your pharmaceutical development and commercialization strategy.


March 29th, 2017

DESI Drugs: Potential Targets for Quick Approvals

September 13th, 2015

Enforcement Activities: FDA Removes Unapproved Prescription Ear Drops

July 20th, 2015

Final Rule—Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs?

March 25th, 2013

Are 505(b)(2)’s “Super Generics” or What Do We Call Them?

December 21st, 2011

What is an Approved DESI Product?

October 3rd, 2011

Don’t Launch Unapproved Products After 9/19/2011

May 19th, 2010

505(b)(2) Product Gains Revenue with FDA Actions Against DESI’s

January 19th, 2010

DESI to 505(b)(2) Raises Drug Costs

December 22nd, 2009

Getting Unapproved Drugs (DESI, etc.) Approved

November 20th, 2009

Qutenza: Approval of a “DESI-inspired” Drug

October 14th, 2009

Codeine Sulfate: FDA Continues Drive to Remove Unapproved Products, With a Twist

September 21st, 2009

More DESI Tannates Removed from Market

September 8th, 2009

DESI Presentation: Q&A

June 1st, 2009

What are DESI Drugs?

April 22nd, 2009

DESI + Non-cGMP = Recall

April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

December 16th, 2008

What is an NME?

November 25th, 2008

Medicaid Paid for Unapproved DESI Drugs

October 13th, 2008

Drug Repositioning Summit 2008

September 23rd, 2008

Another DESI in Discretion

September 16th, 2008

More DESI-Products Cited. Exceptions are Noted for Unique Products.

August 4th, 2008

KV’s DESI Guaifenesin Trumped by Adam’s 505(b)(2) Product

April 15th, 2008

Is Your Drug Project a 505(b)(2), ANDA or OTC?

February 7th, 2008

Another “Unapproved” Drug Needs a 505(b)(2) Approval

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