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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Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended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. By Jeffrey K.

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

pharmaphorum

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

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Sanofi extends its Pompe range with first Nexviazyme OK

pharmaphorum

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. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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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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Sudafed Dosage, Uses, and Side Effects

BuzzRx

Keeping Sudafed products behind the counter, along with other regulations, was mandated by the FDA in 2006 because pseudoephedrine, the main ingredient in Sudafed products, can be used illegally to make methamphetamine. Sudafed Dose Follow the directions on the product label or your doctor’s instructions carefully.

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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. What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Figure 1: Changes in the European Commission’s proposal for pharmaceutical legislation fall under seven key themes, based on L.E.K. analysis (Source: L.E.K) In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.