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Glaucoma

RX Note

External Links American Academy of Ophthalmology - Glaucoma MSD Manual Professional - Glaucoma Meta-analysis of the efficacy and safety of alpha2-adrenergic agonists, beta-adrenergic antagonists, and topical carbonic anhydrase inhibitors with prostaglandin analogs, 2010 Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% (..)

Dosage 52
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Endometriosis

RX Note

Aromatase inhibitors, e.g. letrozole, anastrozole - Off-label use Surgical management of endometriosis is indicated for treatment of severe pain or infertility. 114: management of endometriosis, 2010 NICE Endometriosis: diagnosis and management, 2017 External Links Therapeutic Guidelines - Endometriosis Practice bulletin no.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Amicus’ Opfolda wins positive CHMP opinion in Pompe Disease

Pharmaceutical Technology

Sanofi markets avalglucosidase alfa as Lumizyme in the US to treat LOPD since its approval in 2010. Sanofi’s Nexviazyme generated €196m ($215m) in global revenues in 2022, while Lumizyme was associated with €958m ($1.05bn) according to the company’s full-year report.

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Provention faces delay in FDA review of diabetes prevention antibody

pharmaphorum

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

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Sanofi extends its Pompe range with first Nexviazyme OK

pharmaphorum

In 2010, Lumizyme’s label was expanded to the under-right group as well. 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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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.