June 2012 Safety Labeling Changes includes 35 products with revisions to Prescribing Information

The MedWatch June 2012 Safety Labeling Changes posting includes 35 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.



The "Summary Page" provides a listing of drug names and safety labeling sections revised.

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:

Avodart (dutasteride)
Bepreve (bepotastine besilate) 1.5% ophthalmic
CellCept (mycophenolate mofetil)
CellCept (mycophenolate mofetil hydrochloride)
Estraderm (estradiol) transdermal
Helidac Therapy (bismuth subsalicylate, metronidazole and tetracycline hydrochloride)
Incivek (telaprevir)
Jalyn (dutasteride and tamsulosin HCL)
Methergine (methylergonovine maleate)
Myfortic (mycophenolic acid)
Noxafil (posaconazole)
Prezista (darunavir)
Prinivil (lisinopril) tablets and
Prinzide(lisinopril/hydrochlorothiazide)
Privigen Immune Globulin Intravenous (Human) 10%
Stelara (ustekinumab)
Strattera (atomoxetine hydrochloride)
Sustiva (efavirenz)
Vesicare (solifenacin succinate)
Zithromax (azithromycin)
Sustainable Healthcare Packaging Solutions That Work
Industry leaders share proven strategies for reducing packaging emissions by up to 70% while meeting safety and regulatory requirements.
Read More
Sustainable Healthcare Packaging Solutions That Work
List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO