Drugs

FDA Denies Ipsen Somatuline Depot Petition

FDA has denied an Ipsen Pharmaceuticals 10/15/2019 petition asking that the agency take specific actions on any ANDA that references Ipsen’s Somatuline Depot (lanreotide acetate) subcutaneous solution. The FDA 5/21 response says Ipsen asked that FDA require:

ANDA applicants referencing Somatuline Depot to demonstrate bioequivalence through an in vivo study capable of demonstrating that a proposed generic product causes lanreotide acetate to release into systemic circulation at the same rate and to the same extent as the reference-listed drug (RLD) for the dosing interval;
ANDAs to include comparable impurity analysis on samples of finished drug products and control for peptide-related impurities to the same extent and same level as the RLD;
ANDAs to include comparative performance testing of the delivery device to ensure it is equivalently functional and useable;
ANDA sponsors to conduct a partial Area Under the Curve analysis as part of the in vivo bioequivalence study to ensure the generic is bioequivalent to the RLD over the required dosing interval; and
FDA to reissue its 7/2014 product-specific draft guidance based on its action on the petition.

The FDA petition denial made these points:

the petition failed to show that in vivo bioequivalence evidence is required;
FDA will assess a proposed generic drug’s impurity profile at the time of review and determine if it is acceptable;
FDA does not agree that all ANDAs referencing Somatuline Depot should be required to include comparative use human factors data;
for multiple reasons, FDA does not agree that ANDA applicants for generic Somatuline Depot should be required to perform a partial Area Under the Curve analysis; and
since the petition action requests are denied, there is no need to reissue the product-specific guidance.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome