Hectorol I.V. Clinical Development
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Hectorol I.V. Clinical Development
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<table cellspacing="1" cellpadding="7" width="312" border="1"> <tbody> <tr> <td valign="top" bgcolor="#ffffff" height="16"> <br /> <br /> <p> <font face="Times" size="5">Hectorol I.V. Clinical Development</font> </p> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff" height="16"> <p> <b><i><font face="Times" size="4">NDA Chronology (#21-027)</font></i></b> </p> </td> </tr> </tbody> </table> <table cellspacing="1" cellpadding="7" width="311" border="1"> <tbody> <tr> <td valign="top" width="27%" height="15"> <p> <b><font face="Helvetica Condensed" size="1">Date</font></b> </p> </td> <td valign="top" width="73%" height="15"> <p> <b><font face="Helvetica Condensed" size="1">Action</font></b> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">June 1997</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Division of Metabolic and Endocrine Drug Products approves protocol for pivotal studies</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">1/31/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Bone Care International submits NDA</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">3/17/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">FDA meeting during which division says the application is not fileable</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">4/1/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Refuse-to-file letter issued</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">4/9/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Informal meeting between BCI and FDA to discuss refuse-to-file letter</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">4/14/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">BCI clarifies issues in refuse-to-file letter, asks that application be filed over protest</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">7/16/1999 7/30/1999 8/12/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Teleconferences to discuss filing status and trial design</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">9/3/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Medical reviewer Leo Lutwak reiterates desire for a new trial protocol</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">9/14/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">BCI suggests using bioequivalence to oral formulation</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">9/17/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">BCI counsel Jur Strobos letter proposing five strategies that would allow approval of the NDA</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">10/21/1999</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">NDA filed over protest</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">1/27/2000</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Telecon in which BCI argues that pharmacological equivalence to tablet formulation makes I.V. "approvable"</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">2/3/2000</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Medical team leader recommends NDA for approval</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">3/24/2000</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Statistical reviewer recommends approval</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">4/3/2000</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">Lutwak maintains NDA is "not approvable" because of lack of concurrent controls and concerns about study subjects not being representative of target population</font> </p> </td> </tr> <tr> <td valign="top" width="27%" height="15"> <p> <font face="Helvetica Condensed" size="2">4/6/2000</font> </p> </td> <td valign="top" width="73%" height="15"> <p> <font face="Helvetica Condensed" size="2">NDA approved</font> </p> </td> </tr> </tbody> </table> |