ISTA pulls Vitragen request for marketing authorization
ISTA Pharmaceuticals has withdrawn its marketing authorization application for Vitragen.
ISTA Pharmaceuticals has withdrawn its marketing authorization application for Vitragen.
Vitragen (hyaluronidase), a powder solution for injection, was intended for use in the treatment of vitreous haemorrhage to improve visual acuity (VA) and to facilitate the physician's ability to diagnose the underlying retinal pathology.
In an official letter to the European Medicines Agency (EMEA), the company stated that the withdrawal was based on the Committee for Medicinal Products for Human Use's (CHMP) request for additional information, which ISTA was unable to respond to within the permitted timeframe.
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