Drugs

Organon Wants Generic Nexplanon Restrictions

Organon is asking FDA to impose requirements on any ANDAs that cite its Nexplanon (etonogestrel implant) as the reference-listed drug. The company’s 3/1 petition asks that the agency specifically:

require that an ANDA applicant establish bioequivalence (BE) of the generic drug through (1) an in vivo BE study with pharmacokinetic endpoints evaluating the full duration of the approved, labeled in-use period of Nexplanon, which is the duration of use for which the generic contraceptive implant also would be labeled; or (2) a validated in vivo-in vitro correlation model covering the labeled duration of use; and require that the ANDA applicant conduct comparative dissolution testing profiles in three different media and data on dissolution profile comparison in water;
to the extent that FDA determines that a proposed ANDA product does not need to demonstrate BE as described above, it should require a demonstration of physiochemical and structural sameness between the proposed ANDA product and the reference-listed drug;
require generic etonogestrel implants to have equivalent device constituents;
require an ANDA applicant to implement measures to ensure appropriate training on the use of the generic product; and
revise the agency’s product-specific guidance for etonogestrel implants to reflect the above requirements.

Organon says that while it supports access to safe and effective generic contraceptive products, including generic etonogestrel implants, it has concerns that an 8/2022 FDA draft product-specific guidance on etonogestrel will not ensure the approval of safe and effective generic etonogestrel implants.

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

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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