| Press Release | Source: Adams Respiratory Therapeutics, Inc. |
Adams Respiratory Therapeutics Comments on Possible ANDA Filing of an Extended-Release Formulation of Guaifenesin
Thursday August 17, 7:28 pm ET
CHESTER, N.J., Aug. 17 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. reports today that it has been contacted by a company claiming to have submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA) for a single-ingredient extended-release formulation of guaifenesin.
Mucinex® is the only FDA-approved, extended-release, single-ingredient guaifenesin product. Adams believes that there are at least two hurdles for this competitor to enter the OTC market. First, Adams' NDA approval of Mucinex® was based on rigorous scientific criteria. Adams will urge the FDA to apply these same scientific standards to this ANDA filing as it applied to the Company's NDA filing for Mucinex®.
Secondly, Adams has two patents that protect its suite of extended-release bi-layer tablet products. These patents are listed in the FDA Orange Book and expire in 2020.
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