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Mylan
MYL today announced that it has received all regulatory approvals and has completed an agreement with Pfizer for the exclusive worldwide rights to develop, manufacture and commercialize a novel long-acting muscarinic antagonist (LAMA) compound for various indications.
Mylan expects that this product, which is ready to enter Phase IIb, will be submitted to the U.S. Food and Drug Administration (FDA) for approval as a new chemical entity, and expects the product to benefit from long-term patent protection in the U.S. through 2029. Mylan expects to further develop this compound into combination therapies and that these products will utilize the multi-dose dry powder inhaler technology, also licensed from Pfizer.
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