post-marketing commitment

post-marketing commitment

One or more studies that a new drug applicant has agreed to conduct but which may not meet statutory purposes and thus are not required.
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The drug is yet to be indicated in any population for the treatment of PGTC seizures and the phase three study was a post-marketing commitment made by Pfizer to the US Food and Drug Administration (FDA).
In addition, as part of Aegerion's post-marketing commitment to both the FDA and the EMA, the Company will conduct an observational cohort study to generate more data on the long-term safety profile of lomitapide, the patterns of use and compliance and the long-term effectiveness of controlling LDL-C levels.
Genzyme had already been preparing to submit results from this study to the FDA to fulfill a post-marketing commitment. Genzyme anticipates that this process will culminate in the availability of two commercial versions of Myozyme in the United States: one produced at the 160L scale and the other produced at the 2000L scale.
"We have asked Pfizer to make a post-marketing commitment to evaluate Celebrex," Dr.
The company's post-marketing commitment includes a clinical study, which will record information about the health status of patients using Revcovi.
The Registry also fulfils a post-marketing commitment to the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency.
The approval of the 20 mg dose fulfills a post-marketing commitment with the US FDA to identify the minimum effective dose of vilazodone.
The trial was conducted to fulfil a post-marketing commitment needed by the US Food and Drug Administration when Lyrica was approved to manage fibromyalgia.
M2 EQUITYBITES-September 2, 2014-Takeda Pharmaceutical completes post-marketing commitment and submissions of data from epidemiology study to regulatory authorities
M2 PHARMA-September 2, 2014-Takeda Pharmaceutical completes post-marketing commitment and submissions of data from epidemiology study to regulatory authorities
Post-marketing commitments for RAPIVAB are ongoing.
As a holder of the CPRs for Dengvaxia and Dengvaxia MD, Sanofi is bound by post-marketing commitments, including the submission of Risk Management Plans (RMP).
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