Note: As outlined in the Proposed Criteria for First Generic Submissions for Purposes of ANDA , certain ANDAs are deemed “first generic” for the purposes of review prioritization. In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities; and (2) for which there is no previously-approved ANDA for the drug product.
*This table reflects current data as of the date the listed approval was made. Post-approval status changes, including approved use or indications, approval date, approval status, etc. are not reflected here. To view the most current information on any ANDA listed, please check its Drugs@FDA listing.
+Due to space limitations, abbreviated indications are listed. For full indication information, please check Drugs@FDA .
The partition coefficient of the ester in question is important because is effects how long the drug itself stays in the system. If the testosterone transfers too quickly from the oil to the blood, the result is a sudden spike in testosterone which then rapidly drops once the dose has been used up. In the example of free testosterone injected into the muscle from a water suspension (as in Aquiviron, mentioned above), the testosterone is essentially immediately available to the bloodstream due to its low partition coefficient, and thus there is an immediate spike of testosterone which is used up quickly in the body.