This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218813.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections
Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder
Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
Avodart (dutasteride) soft gelatin capsules
Brovana Inhalation Solution (arformoterol tartrate)
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container
Copegus (ribavirin) tablets
Foradil Aerolizer (formoterol fumarate inhalation powder)
Heparin Sodium injection
Hycamtin (topotecan hydrochloride) capsules
Kaletra (lopinavir/ritonavir) tablets and oral solution
Novantrone (mitoxantrone HCl) injection
Ovidrel (choriogonadotropin alfa injection) prefilled syringe
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet
Serevent Diskus (salmeterol xinafoate) inhalation powder
Solu-Medrol (methylprednisolone sodium succinate) for injection
Symbicort Inhalation Aerosol (budesonide and formoterol)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218813.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections
Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder
Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
Avodart (dutasteride) soft gelatin capsules
Brovana Inhalation Solution (arformoterol tartrate)
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container
Copegus (ribavirin) tablets
Foradil Aerolizer (formoterol fumarate inhalation powder)
Heparin Sodium injection
Hycamtin (topotecan hydrochloride) capsules
Kaletra (lopinavir/ritonavir) tablets and oral solution
Novantrone (mitoxantrone HCl) injection
Ovidrel (choriogonadotropin alfa injection) prefilled syringe
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet
Serevent Diskus (salmeterol xinafoate) inhalation powder
Solu-Medrol (methylprednisolone sodium succinate) for injection
Symbicort Inhalation Aerosol (budesonide and formoterol)
Companies in this press-release
