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.
References in periodicals archive ?
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.
We have asked Pfizer to make a post-marketing commitment to evaluate Celebrex," Dr.
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
This study, a post-marketing commitment required by the FDA, is examining the overall safety and efficacy of FACTIVE tablets in treating CAP versus clarithromycin and in treating acute bacterial exacerbations of chronic bronchitis (ABECB) versus amoxicillin/clavulanate.
4 billion, respectively, and options for an additional clinical study and post-marketing commitments valued at $48 million, which if both were to be exercised in full, would increase the total contract value to up to $1.
The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalise its review of the clinical amendments to the company's post-marketing commitments that were recently submitted.
The agency's approval of Perjeta was conditioned on Genentech's agreement to post-marketing commitments related to the manufacturing process for the product.
The company is also pending final agreements between Photocure and FDA on labeling, and post-marketing commitments.