Drugs

FDA Publishes 31 Drug Safety Labeling Changes

FDA has published safety labeling changes for 31 products approved 12/2015, including revised Warnings and Precautions for five multiple sclerosis drugs for cases of thrombotic microangiopathy — Biogen’s Avonex (interferon beta 1a), Bayer’s Betaseron (interferon beta 1b), Novartis’ Extavia (interferon beta 1b), Biogen’s Plegridy (peginterferon beta 1a), and Serono’s Rebif (interferon beta 1a).

New Warnings language also was approved for Genzyme’s Clolar (clofarabine) injection, Pacira’s Exparel (bupivacaine liposome) injectable suspension, AstraZeneca’s Farxiga (dapagliflozin) tablets, Boehringer Ingelheim’s Glyxambi (empagliflozin and linagliptin) tablets, Ariad’s Iclusig (ponatinib) tablets, Hoffmann La Roche’s Invirase (saquinavir mesylate) capsules and tablets, Janssen’s Invokana (canagliflozin) tablets, Janssen’s Invokamet (canagliflozin and metformin HCl) tablets, Boehringer Ingelheim’s Jardiance (empagliflozin) tablets, Janssen’s Ortho-Cept (desogestrel/ethinyl estradiol) tablets, Supernus’ Oxtellas XR (oxcarbazepine) extended-release tablets, Boehringer Ingelheim’s Synjardy (empagliflozin and metformin HCl) tablets, Prism’s Xeljanz (tofacitinib) tablets, AstraZeneca’s Xigduo XR (dapagliflozin and metformin HCl extended release) tablets, Novartis’ Xolair (omalizumab) powder for injection, and Wyeth’s Zosyn (piperacillin and tazobactam) for injection.

Precautions were changed in labeling for Astellas’ Astagraf XL (tacrolimus extended-release capsules), Takeda’s Dexilant (dexlansoprazole) delayed-release capsules, and Takeda’s Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets.

The Adverse Reactions sections were changed in labeling for Genentech’s Avastin (bevacizumab), Roche’s Fuzeon (enfuvirtide) lyophilized powder for injection, Boehringer Ingelheim’s Gilotrif (afatinib) tablets, Hospira’s metronidazole injection, Organon’s Remeron (mirtazapine) tablets and SofTab orally disintegrating tablets, Sanofi-Aventis’ Taxotere (docetaxel) injection concentrate, and Celgene’s Vidaza (azacitidine for injection).

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