Drugs

FDA Denies Amneal Levothyroxine Petition

FDA has denied a 12/21/2018 Amneal Pharmaceuticals petition asking it to (1) change the therapeutic equivalence code published in the Orange Book for all strengths of Provell’s Euthyrox (levothyroxine sodium) tablets from AB2 to BX to mitigate the risk of look-alike medication errors and (2) refuse to approve any sNDA for Euthyrox that seeks approval of bulk or loose packaging of the current off-white tablets without color-coded blister packaging to help distinguish strengths. The agency’s 10/2 denial letter says that during the original NDA review, it raised a concern that the lack of tablet color coding had the potential to increase the risk of medication errors.

In working with the NDA applicant, it says, FDA determined that it would be acceptable to market Euthyrox using the universal color-coding system to denote different dosage strengths on the blister packaging and carton labels only. At the time of a supplement filing, the letter says, FDA reviewed the FDA Adverse Event Reporting System and did not identify errors or confusion regarding the strength of the drug.

The letter further says that the non-color-coded Eythyrox tablets met the criteria for the AB2 therapeutic equivalence code and thus it will not be changed.

The petition request involving sNDAs for a change in packaging was denied, FDA says, because each such request must be considered on a case-by-case basis. “FDA recommends that applicants take steps to minimize risks associated with the design of the drug product and its container closure system,” the letter says, “and will request information regarding potential risks on a case-by-case basis as part of its review of the application.”

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