Drugs

Alcon Wants Specific Ciprodex BE Requirements

Alcon is asking FDA 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. It also asks that the agency revise its product-specific guidance on ciprofloxacin and dexamethasone.

Specifically, the petition calls on FDA to:

require any ANDA applicant citing Ciprodex as the reference-listed product to establish bioequivalence through in vivo clinical endpoint studies or, if the agency retains an in vitro option, through specific studies requested by Alcon;
promptly issue a final version of its product-specific draft guidance consistent with the request for bioequivalence studies;
confirm that ANDA applicants referencing Ciprodex may not rely on in vitro studies alone;
confirm that an ANDA applicant proposing different pH adjusters than those for Ciprodex will not be eligible for approval;
confirm that ANDA applicants cannot obtain approval if the proposed generic product contains a different exception excipient from Cirpodex and the applicant cannot demonstrate that the change does not affect the safety and/or efficacy of the proposed generic product; and
refuse to permit an ANDA applicant to omit Ciprodex’ pediatric AOM (acute otitis media) indication from its labeling or deviate from Ciprodex’ prescribing information with respect to dosage and administration for use in AOM.

The petition says that a recently revised FDA draft guidance that allows an in vitro bioequivalence option departs from the agency’s historic practice for topical products such as otic suspensions and diverges from its original 2012 draft guidance.

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