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10 Apr 2012, 3:53 pm
FDA also states in the petition response that the Agency approved three ANDAs for generic VANCOCIN, including one from Akorn, Inc. [read post]
7 Apr 2021, 1:20 pm
The Data Summary section of the Belviq FDA Drug Safety Communication set forth these findings from the Belviq safety clinical trial: Imbalances in specific cancers including pancreatic, colorectal, and lung contributed to the observed overall imbalance in cancer cases. [read post]
1 Apr 2012, 11:22 am
There is little safety data with the new drugs on big groups of patients, including the elderly, people with impaired kidney function and patients with significant valvular heart disease. [read post]
1 Mar 2012, 3:16 am
Vivus resubmitted the drug this year with new data in an effort to prove that the drug’s benefits outweigh the risks. [read post]
11 Jan 2021, 1:19 pm
Hikma Pharmaceuticals USA Inc., Case No. 2:16-cv-02525-MMD-NJK (D. [read post]
20 Sep 2007, 3:04 pm
This medication, made by the drug company Cephalon, Inc., is prescribed to treat patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea / hypopnea syndrome (OSAHS), and shift work sleep disorder. [read post]
16 Mar 2015, 9:23 am
In August 2014, Johnson & Johnson and Bayer AG announced plans to launch more clinical trials against three new diseases. [read post]
19 Apr 2009, 8:29 am
In addition, this specific Salmonella fingerprint matches a number of other clinical isolates in the PulseNet data base. [read post]
29 Feb 2012, 9:07 am
Details on Qnexa Qnexa is a weight-loss drug manufactured by Vivus Inc. [read post]
28 Jan 2020, 10:47 pm
Practice Fusion was acquired by Allscripts Healthcare Solutions, Inc. in February, 2018. [read post]
8 Jul 2015, 4:30 am
Energizer Holdings, Inc., 962 F. [read post]
23 Mar 2016, 5:15 am
Doctor’s Data, Inc. v. [read post]
18 Jan 2013, 2:06 pm
It encourages the doctor to publish the data, and, because this would otherwise be an off-label use, immediately begins a clinical trial. [read post]
26 Apr 2022, 1:35 pm
Springbok Health Inc. [read post]
6 May 2019, 5:44 pm
Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) shows the Covered Entity breached the privacy, data security, business associate agreement and breach notificataion rules of the Health Insurance Portability and Accountability Act (HIPAA) Security and Breach Notification Rules before or after the breach. [read post]
18 Jan 2012, 4:27 am
Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. [read post]
28 Feb 2019, 5:28 pm
Here, the failed element was providing “immediate relief” after administration of the generic Pepcid Complete Brigham & Women’s Hospital, Inc., v. [read post]
31 Jul 2013, 6:30 am
©2013 Amaxx Risk Solutions, Inc. [read post]
24 Jul 2014, 12:54 pm
However, the regimen in the '209 Patent actually improved the efficacy of the drug over unsupplemented clinical trials. [read post]
19 Dec 2013, 6:12 am
FDA, ODE, “Summary Of Safety And Effectiveness Data (SSED) − Clinical Section Checklist,” at 6 (June 10, 2010) (emphasis added). [read post]
