Questa traduzione è in preparazione. Nel frattempo mostriamo temporaneamente la versione originale in inglese.
Imprese · 25/09/20011 min di lettura
Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications
Traduzione automatica locale · Lingua originale della fonte
Riepilogo
The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDAs) held by Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. In 1997, the agency informed Solvay of its intention to assess the validity of data and information in all of Solvay's pending and approved applications. However, Solvay does not intend to conduct validity assessments of the two NDAs named in this notice because the products are no longer marketed. Solvay has agreed to permit FDA to withdraw approval of the applications, thereby waiving its opportunity for a hearing.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →