Drugs

Ipsen Asks Somatuline ANDA Restrictions

Ipsen is asking FDA to require that any proposed generic form of its Somatuline Depot (lanreotide acetate) for subcutaneous injection be tested in vivo to assure that it is bioequivalent to the reference-listed drug (RLD). “Based on Ipsen’s many years of experience with the product,” the company petition says, “and our understanding of the many variables that may impact the product, Ipsen does not believe patient safety and patient benefit can be assured if a generic version of Somatuline Depot were to be approved without testing in human subjects.”

Specifically, the petition asks that FDA:

require ANDAs that reference Somatuline Depot to demonstrate bioequivalence by conducting an appropriate comparative in vivo study capable of demonstrating that a proposed generic drug product causes lanreotide acetate to release into systemic circulation at the same rate and to the same extent as the RLD over the course of the dosing interval;
require that ANDAs include comparative impurity analysis on samples of finished drug product and control for peptide-related impurities to the same extent and same level as the RLD;
require that ANDAS include comparative performance testing of the delivery device to ensure it is equivalently functional and useable;
require ANDA sponsors to conduct 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
re-issue a draft guidance based on the actions taken in response to the petition.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

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