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29

September
2014

category:

503b Compounding

Clinigen Group plc Receives FDA’s First Ever Drug Shortage Assistance Award

URTON-ON-TRENT, England, Sep 29, 2014 (BUSINESS WIRE) — Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA)in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection. […]

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29

September
2014

category:

503b Compounding

FDA: Eye drops recalled over flawed production

THE Food and Drug Administration (FDA) announced Thursday the voluntary recall of a particular batch of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) owing to its supposed failure to meet Good Manufacturing Practice (GMP). According to FDA Advisory No. 2014-071, Novartis Healthcare Philippines Inc. ordered the recall of the product’s Batch No. […]

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24

September
2014

category:

503b Compounding

Pharmacies banned from compounding for docs without prescription

The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients. http://www.in-pharmatechnologist.com/Regulatory-Safety/Pharmacies-banned-from-compounding-for-docs-without-prescription

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