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Labelling of Dispensed Medicine

RX Note

Labelling Requirements A ll dispensed medicine should be labelled according to the requirement stated by the law. NOTE: It is advisable for labels to be printed. Consequently, a patient-centred label strategy is introduced to promote appropriate medication use and adherence. Suggestions include Use larger font sizes (e.g.

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STAT+: GSK is replacing its popular Flovent inhaler with authorized generics, raising cost concerns for asthma patients

STAT

Flovent’s manufacturer, GSK, has discontinued both versions of the product — Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder — and replaced each with what is known as an “ authorized generic ,” essentially the same product sold under a private label. Prasco, a U.S.

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DEA Regs Bulk Up with 2014 Anabolic Steroid Control Law Additions

FDA Law Blog: Biosimilars

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

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Amgen builds Otezla’s psoriasis label as rival BMS looms large

pharmaphorum

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The post Amgen builds Otezla’s psoriasis label as rival BMS looms large appeared first on.

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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin. Inspection categorisation of Official Action Indicated (OAI) for Indian companies has decreased to 11 per cent in 2024 from 23 per cent in 2014, aligning with the global trend of 14 per cent in 2024.

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog: Biosimilars

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

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FDA grants swift review to Lynparza in first-line prostate cancer

pharmaphorum

Lynparza was approved in 2020 as a second-line therapy for homologous recombination repair (HRR) gene-mutated mCRPC last year, but extending its label to include non-HRR patients in the frontline setting would dramatically increase the number of patients eligible for treatment. billion in the first half of this year.

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