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November 4th, 2009

GTx Needs a 2nd Phase III Trial and More Safety Data

September 14th, 2009

A Treatment IND is NOT the Same as an IND

May 29th, 2009

MAP Pharmaceuticals 505(b)(2) Dihydroergotamine Orally Inhaled Product Meets Phase 3 Goals

May 15th, 2009

505(b)(2) IV Acetaminophen

May 15th, 2009

Quick-release Bromocriptine Mesylate Approved

April 17th, 2009

505(b)(2) Program: BTG’s Paxclitaxel Gel for Oesophageal Cancer

March 19th, 2009

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

February 2nd, 2009

Dexlansoprazole Approved for the Treatment of GERD

January 29th, 2009

Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA

December 3rd, 2008

505(b)(2) Combination Meets Phase 3 Goals

August 22nd, 2008

Modeling Using Dissolution Data

June 7th, 2008

Indevus’ Stock Drops 70% on FDA’s Request for More Safety Data

April 23rd, 2008

505(b)(2) Patent & Marketing Exclusivity

February 7th, 2008

A Single Phase 3 Trial Needed for 505(b)(2) Approval of a Combination Drug

January 17th, 2008

505(b)(2) with Only Phase 1 Study

January 16th, 2008

505(b)(2)—Part 2: The Assessment: Timeline, Cash Flows

December 12th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Marketing Assessment

December 7th, 2007

505(b)(2)—Part 2: The Assessment: Clinical Pharmacology

December 1st, 2007

505(b)(2)—Part 2: The Assessment: Pharmacokinetic Review

November 16th, 2007

505(b)(2) Combo Plavix/Prilosec

November 8th, 2007

505(b)(2)—Part 2: The Assessment: Safety Review

October 28th, 2007

505(b)(2)—Freedom from Generic Competition—Exclusivity Issues

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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

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