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Articles
What injections can be given orally or via enteral feeding tubes?
Safety in Lactation: Antimuscarinic drugs
Safety in Lactation: Drugs for obstructive airways disease
Lactation Safety Information
For premedication and bradycardia
Glycopyrrolate as an antiperspirant and in iontophoresis
Inhalation
as a bronchodilatorNew Medicines
Qbrexza
Hyperhidrosis - primary axillary in patients aged 9 years and older in the form of a solution applied via disposable cloths (wipes).Information
Development and Regulatory status
Dec 19: UK and European launch unclear; 2018 form 10-k states "We may also partner with third parties to help us reach other geographic markets or therapeutic specialties" [12].
Sep 18: Launched the US for the treatment of primary axillary hyperhidrosis in adults and paediatric patients aged 9 years and older [11].
Jul 18: Launch of Qbrexza in the US planned for October 2018 and Dermira are looking at additional indications, e.g. hyperhidrosis of hands, feet and face [10].
Jun 18: FDA approves Qbrexza for topical treatment of primary axillary hyperhidrosis [8].
Nov 17: Dermira announced that the FDA has accepted the NDA for topical glycopyrrolate for the treatment of primary axillary hyperhidrosis. They intend to market it in the second half of 2018 [7].
Jun 16: Dermira plans to submit an NDA to the FDA for approval of DRM04 in H2 2017, subject to it completing the PIII ARIDO trial, an open-label trial assessing the long-term safety of DRM04 [1].