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Review Classification The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritizing their review.
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Data extraction and classification process. After the databases were searched and duplications were removed, each article was reviewed (JS, IW) and data were extracted and classified independently by two reviewers (LB, AM). If required, a third independent reviewer (LS) was consulted to resolve any discrepant classifications. The extracted data.
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Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant used for the relief of painful and uncomfortable muscle spasms caused by a variety of conditions. It is known to be particularly useful in treating muscle spasticity associated with spinal cord injury (FDA label). This drug has recently been studied for the management of alcohol withdrawal, however, a.
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The present invention is directed to compounds of Formula I: or a pharmaceutically acceptable salt thereof, wherein the substituents R1, R3, R6, R7, and b are as defined herein. The invention is also directed to pharmaceutical compositions comprising the compounds, methods of treatment using the compounds, and methods of preparing the compounds.