Drugs

Zydus Petition on Indocin Suppositories

Zydus Pharmaceuticals submitted a 9/14 petition asking FDA to take certain actions concerning Indocin (indomethacin) suppositories, 50 mg, and its generic equivalent. The petition says the International Conference on Harmonization (ICH) standards and established drug product impurity acceptance criteria should be followed by ANDA sponsors and applicants, given the risks associated with impurities exceeding established limits and the therapeutic utility of indomethacin suppositories.

The petition specifically asks that FDA take the following steps considering the risks presented by a high amount of unknown organic impurities in indomethacin suppositories:

ensure that the currently marketed Indocin suppositories SR for indomethacin suppositories, 50 mg, approved under ANDA 073314 comply with ICH guidelines and established impurity acceptance criteria; and
ensure compliance as per ICH guideline and established impurity acceptance criteria before approving any ANDA for indomethacin suppositories, 50 mg, which only justifies any higher impurity levels citing the results of the currently marketed Indocin suppositories SR without providing any adequate scientific justification for any higher impurities levels.

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