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FDA requires makers of testosterone drugs to change labels

FDLI SmartBrief | Mar 04, 2015

The FDA on Tuesday issued a ruling that will require makers of testosterone drugs to include a new warning on their labels and would prohibit them from marketing their products for age-related low testosterone. The warning labels will need to specify that the products are only meant for use by men with certain conditions and add information about the possible increased risk for heart attack and stroke. Reuters (03/03)


Janssen ordered to pay $2.5M in damages over Risperdal case

FDLI SmartBrief | Feb 26, 2015

Nestle Purina PetCare dog food is target of class-action lawsuit

FDLI SmartBrief | Feb 27, 2015

FDA to release new guidance on biosimilar labeling, generic opioids

FDLI SmartBrief | Mar 02, 2015

Ranbaxy loses bid to lift FDA revocation of approvals of generic drugs

FDLI SmartBrief | Mar 02, 2015

S.C. Supreme Court upholds verdict against Janssen in Risperdal case

FDLI SmartBrief | Feb 27, 2015

Docs overprescribe antipsychotic drugs for dementia patients, GAO finds

FDLI SmartBrief | Mar 03, 2015

Lawmakers pass bill to postpone e-prescribing mandate in N.Y.

FDLI SmartBrief | Mar 03, 2015

Teva's abuse-resistant pain drug accepted by FDA for review

FDLI SmartBrief | Feb 26, 2015

Shire files NDA for dry-eye-disease drug lifitegrast

FDLI SmartBrief | Mar 03, 2015


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