Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.
In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.
In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.
FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.