Drugs

FDA Releases Safety Labeling Changes for 35 Drugs

FDA has released safety labeling changes 35 drugs that were approved 3/2016, including a Contraindication for hypersensitivity in Janssen’s Invega (paliperidone) extended-release tablets and extended-release injectable suspension, Janssen’s Invega Trinza (peliperidone/palmitate) extended-release injectable suspension, and Janssen’s Risperdal (risperidone) tablets, oral solution, and orally-disintegrating tablets, and Risperdal Consta long acting injection.

The labeling Contraindications section also was changed in Janssen’s Invokamet (canagliflozin and metformin HCl) tablets, Janssen’s Invokana (canagliflozin) tablets, Baxter’s Plasma-Lyte 56 and 5% dextrose injection, Genzyme’s Renagel (sevelamer HCl) tablets, Genzyme’s Renvela (sevelamer carbonate) powder for oral suspension, and AstraZeneca’s Tudorza Pressair (aclidinium bromide inhalation powder).

Changes were approved in the Warnings sections of labeling for Seattle Genetics’ Adcetris (brentuximab vedotin) for injection, The Medicine Company’s Angiomax (bivalirudin) lyophilized powder for injection, Bristol-Myers Squibb’s Droxia (hydroxyurea) and Hydrea (hydroxyurea) capsules, AstraZeneca’s Faslodex (fulvestrant) solution for injection, Genentech’s Herceptin (trastuzumab) intravenous infusion, Merck’s Implanon (etonogestrel) implant, Incyte’s Jakafi (ruxolitinib phosphate) tablet, Aegerion’s Juxtapid (lomitapide) capsules, Organon’s Nexplanon (etonogestrel) implants, Actavis’ Oxytrol for Women (oxybutynin) transdermal system, Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets, Novartis’ Xgeva (denosumab, AMG 162; human monoclonal antibody to RANK ligand), and Sandoz’ Zarxio (filgrastim-sndz).

The Precautions sections were changed in labeling for furosemide tablets and US Pharma’s Lasix (furosemide) tablets, Gilead’s Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alfenamide) fixed-dose combination tablet, Roche’s Klonopin (clonazepam) tablets, Janssen’s Prezcobix (darunavir and cobicistat) tablet, and Bristol-Myers Squibb’s Sustiva (efavirenz) capsules and tablets.

Finally, Adverse Reactions sections were changed in labeling for Pharmacia & Upjohn’s Cleocin HCl (clindamycin HCl) capsules, Cleocin phosphate (clindamycin) injection, and (clindamycin injection in 5% dextrose) solution in Galaxy plastic containers, Ipsen’s Increlex (mecasermin [rDNA origin] injection, ThromboGenics’ Jetrea (ocriplasmin intravitreal) injection, Sanofi’s Zaltrap (ziv-aflibercept) injection, and Novartis’ Zometa (zoledronic acid) injection.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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