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)
Recyclable pill bottles are gaining pharmacy ground
Aluminum and paper-based prescription bottles are moving from concept to commercial reality. Here's what pharmacy and packaging leaders need to know.
Read More
Recyclable pill bottles are gaining pharmacy ground
Fresh from the show floor: pharma packaging innovations for 2026
Serialization mandates. Containment demands. Sterile barrier requirements. Our editors found the pharma packaging innovations addressing your biggest challenges at PACK EXPO Las Vegas. Get your free curated report now.
GET YOUR COPY
Fresh from the show floor: pharma packaging innovations for 2026