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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Provention faces delay in FDA review of diabetes prevention antibody

pharmaphorum

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

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Does gabapentin help you sleep?

The Checkup by Singlecare

Gabapentin is a prescription medication that is FDA-approved to treat epilepsy and neuropathic pain caused by shingles. Healthcare providers often prescribe it for other off-label uses as well, including anxiety , bipolar disorder , and fibromyalgia. Gabapentin is used off-label for many conditions, including sleep.

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Sanofi extends its Pompe range with first Nexviazyme OK

pharmaphorum

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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Amicus’ Opfolda wins positive CHMP opinion in Pompe Disease

Pharmaceutical Technology

The treatment will go up against Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) which received an EC approval in June 2022, following a US Food and Drug Administration ( FDA) approval in August 2021. Sanofi markets avalglucosidase alfa as Lumizyme in the US to treat LOPD since its approval in 2010.

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Can you take Tylenol and Motrin together?

The Checkup by Singlecare

RELATED: Ibuprofen savings | Acetaminophen savings Multiple studies, including a 2010 study focused on pain treatment after oral surgery, found the alternating ibuprofen and acetaminophen to be successful. Follow the proper label instructions for each. Canadian Family Physician (2012) Maxigesic Rapid® tablets gain US FDA approval.

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Ibuprofen interactions to avoid

The Checkup by Singlecare

Keep a regular schedule : Taking ibuprofen as directed by the label or a healthcare provider can help ensure the drug is taken effectively and safely. Read labels on nonprescription products: Check the labels of OTC cold and pain medications. Many products contain ibuprofen and other NSAIDs as added ingredients.