Lactation Safety Information
For premedication and bradycardia
Glycopyrrolate as an antiperspirant and in iontophoresis
Inhalationas a bronchodilator
QbrexzaHyperhidrosis - primary axillary in patients aged 9 years and older in the form of a solution applied via disposable cloths (wipes).
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" .
Sep 18: Launched the US for the treatment of primary axillary hyperhidrosis in adults and paediatric patients aged 9 years and older .
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 .
Jun 18: FDA approves Qbrexza for topical treatment of primary axillary hyperhidrosis .
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 .
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 .