Drugs

FDA OKs Alcon-sought Bioequivalence Parameters for Ciprodex

FDA has partially approved an Alcon citizen petition that asked the agency to require only in vivo bioequivalence testing for ANDAs that cite its Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) sterile otic suspension as the reference-listed drug. The petition said that a recently revised FDA draft guidance that allows an in vitro bioequivalence option departs from the agency’s historic practice for topical products such as otic suspensions and diverges from its original 2012 draft guidance. An FDA letter to Alcon says the petition is granted to the extent that it requested the agency to:

Confirm that an ANDA applicant who lists Ciprodex as the reference-listed drug may not rely on in vitro studies alone to establish bioequivalence if the applicant proposes a change in tonicity agent.
Confirm that an ANDA applicant may not obtain approval if the proposed product contains a different exception excipient from Ciprodex and the applicant cannot establish that the change does not affect safety or efficacy.
Confirm that an ANDA applicant who proposes different pH adjusters than those used in Ciprodex will not be eligible for approval.

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