Over the past two plus years, Mallinckrodt has been systematically completing all legacy studies that had been initiated by the previous owner of H.
This multicentre two part Phase 4 trial will assess the efficacy and safety of the company 's H.
Food and Drug Administration (FDA) previously granted the company's request for a Fast Track designation and orphan status for its H.
For instance, two randomized clinical trials were conducted to support the effectiveness of the drug in obtaining FDA approval as a treatment for infantile spasms, one of which compared H.
Biopharmaceutical company Questcor Pharmaceuticals Inc (NasdaqGS:QCOR) said on Tuesday that it will launch a Phase 2 study to explore the efficacy and safety of the FDA approved H.
The company has been Questcor Pharmaceuticals manufacturing partner for API in its H.
For nearly, a decade BioVectra, which has been Questcor's manufacturing partner for the API in Questcor's H.
The US market is dominated by two approved products H.
Previously, the FDA granted Orphan Designation to H.
The decrease in the first nine months of 2005 also reflected reduced spending on sales and marketing, lower Acthar site transfer expenses and lower payroll-related costs, partially offset by increased spending on outside services and routine stability testing of H.