Drugs

FDA Denies Synergy Pharmaceuticals’ Linzess Petition

FDA has denied a 2/26/18 Synergy Pharmaceuticals petition asking that the agency require specified revisions to the approved package insert for Forest Laboratories’ Linzess (linaclotide) capsules. The petition asked that FDA:

convert the Trial 5 safety data for the Linzess 72 mcg dose in patients treated for chronic idiopathic constipation (CIC) from narrative to tabular form;
add an additional column to Table 2 to reflect adverse events for the 290 mcg dose with a specified footnote;
add an additional paragraph to the Adverse Reactions Leading to Discontinuations section with wording specified in the petition; and
add an asterisk to Tables 1 and 2 as well as the additional table proposed in the petition to reflect adverse events in Trial 5 with wording specified in the petition.

Synergy said that based on its review of publicly available information on the Linzess clinical trial protocols and clinical trial data it had determined that the prescribing information failed to include adequate information for the drug’s use because it misrepresented or obfuscated the incidence of adverse events from the clinical trials in several respects.

FDA responded that based on its review and on information submitted by Allergan in response to the petition, it did not agree with Synergy on any of its concerns and thus denied the petition.

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