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However, these diseases are not curable. The company previously announced that it was pursuing FDA approval of its Cocaine HCl drug products as an anesthetic prior to a diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities. A Lannett-sponsored clinical study is currently recruiting subjects. We are denying the requests in your petition pertaining to oxycodone HCl on two principal grounds. First, we reject your implicit contention that oxycodone HCl products as a class are “grandfathered” under the 1938 grandfather clause. Furthermore, the evidence provided with your petition is inadequate to demonstrate that Lannett’s Oxycodone HCl Product meets the requirements of the 1938 grandfather clause. Combining this using rutin, yet another bioflavonoid, will take this prevention into a whole new level.
An 11-count indictment was unsealed earlier today against USPlabs LLC, a Dallas firm, which formerly manufactured highly popular workout and weight loss supplements. Furthermore, the evidence provided with your petition is inadequate to demonstrate that Lannett’s cocaine HCl Products meets the requirements of the 1938 grandfather clause. Although FDA’s petition decision is largely a repeat of the Agency’s previous decision with respect to Oxycodone HCl, it’s worth a read if just to provide a refresher on how narrowly FDA interprets the 1938 grandfather clause.