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Samples in periodicals archive:
Food and Drug Administration (FDA) to market and sell NAVIGATOR(R) (32% nitazoxanide) Antiprotozoal Oral Paste, a new treatment for equine protozoal myeloencephalitis (EPM), a progressive, degenerative disease of the central nervous system that can cause serious or even fatal neurological problems in horses.
Sarcocystis neurona is a parasite responsible for Equine Protozoal Myeloencephalitis (EPM).
Food and Drug Administration (FDA) providing comments to the Company regarding its application for approval of nitazoxanide, a product for the treatment of equine protozoal myeloencephalitis (EPM).
IDEXX Pharmaceuticals also has a number of products in the registration process with the FDA, including a nitazoxanide-based product for treatment of equine protozoal myeloencephalitis -- a neurological disease that is believed to affect approximately 200,000 horses in the US; a topical non-steroidal anti-inflammatory for equine use; an insulin product for the treatment of diabetic cats; and a long-acting injectable antibiotic for cats are also in development.
Food and Drug Administration has informally told the Company that it is likely to issue an incomplete letter regarding the Company's new animal drug application (NADA) for nitazoxanide, a drug intended for the treatment of equine protozoal myeloencephalitis.
The Company is seeking FDA approval of a number of other drugs for companion animals, including a treatment for equine protozoal myeloencephalitis (EPM), a non-steroidal anti-inflammatory, and a novel, long-acting antibiotic for companion animals.
The new company is a leading-edge veterinary biotechnology company whose first product is the world's only reliable test for equine protozoal myeloencephalitis (EMP), which causes severe damage to horses' central nervous systems.