Perrigo announces FDA approval of generic version of Astepro nasal spray Perrigo (PRGO) announced that it has received final approval from the FDA on its Abbreviated New Drug Application for azelastine hydrochloride nasal spray. The ANDA involved contributions from both Perrigo and Impax Laboratories (IPXL), who will share certain costs and benefits of this product. Perrigo and Impax continue to be in first to file Hatch Waxman patent litigation with Meda Pharmaceuticals in the United States District Court for the District of New Jersey. Perrigo has commenced shipment of product to its customers. Annual sales were approximately $97M annually, as measured by Symphony Health Solutions.
Galmed and Perrigo sign agreement for aramchol API production Galmed (GLMD) has entered into a Manufacturing Services Agreement with Perrigo (PRGO) subsidiary Perrigo API Ltd. for the large-scale production of the active pharmaceutical ingredient of Galmed's product candidate, aramchol. The API produced pursuant to this agreement is expected to provide sufficient quantities of aramchol for Galmed's potential future Phase III clinical trials of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH. The agreement also provides Perrigo with the option to manufacture commercial supplies of the aramchol API in the future.