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FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor

pharmaphorum

The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-marketing requirements. “Despite….advantageous

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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Cyberbullying statistics 2022

The Checkup by Singlecare

Google Survey , 2019). The Cyberbullying Research Center , 2019). The Cyberbullying Research Center , 2019). The Cyberbullying Research Center , 2019). UNICEF Poll , 2019). high school students experienced cyberbullying in 2019. In another survey in 2019, 15.7% Ditch the Label , 2017).

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FDA holds back from action over Xeljanz safety study

pharmaphorum

The study was carried out at the request of the FDA, after concerns emerged about the safety of Xeljanz which emerged in 2019, and specifically a possible increased risk of blood clots in the lungs and death, particularly with the higher 10mg approved dose of the drug.

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Gabapentin interactions to avoid

The Checkup by Singlecare

Available under the brand names Neurontin , Gralise , and Horizant , gabapentin is also commonly prescribed off-label for general nerve pain, migraines , and bipolar disorder. Off-label use is when a drug is used for a purpose other than what it is approved for. Side effects of CNS depressants include drowsiness and trouble breathing.

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Does Viagra work for women?

The Checkup by Singlecare

Although it’s not officially approved for female use, some healthcare providers may prescribe it off-label for female sexual dysfunction. The FDA label for Viagra explicitly states it’s not indicated for women or children. Communicating with a partner may also help alleviate anxiety and improve intimacy. Can women take Viagra?