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RFID: The future of smart labelling?

Pharmaceutical Technology

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In recent times, various global administrators have issued regulatory standards.

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Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

The FDA Law Blog

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved.

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FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

pharmaphorum

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

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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. Myozyme was first to market in 2006 for infantile-onset Pompe, with Lumizyme reaching the market four years later to treat late-onset Pompe in children aged over eight.

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Off-label medication options. Janssen’s Risperdal (risperidone), a second-generation antipsychotic , got its first FDA approval for autism-related irritability for children over the age of five, in 2006. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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Does mirtazapine cause weight gain?

The Checkup by Singlecare

Food and Drug Administration ( FDA ) to treat major depressive disorder (depression) in adults, and it is sometimes used off-label as an appetite stimulant. A small 2006 study concluded that mirtazapine was associated with significantly increasing body weight, body fat mass, and leptin concentration.

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AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

pharmaphorum

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. In September last year Mylan and Kindeva argued in the trial that each asserted patent claim is invalid under US patent laws.