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August 26, 2020

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert – Boxed Warning about Risk of Leg and Foot Amputations Removed

[Posted 08/26/2020] AUDIENCE: Patient, Health Professional, Endocrinology, Pharmacy ISSUE: Based on FDA’s review of new data from three clinical trials, the boxed warning about amputation risk […]
August 26, 2020

Integrated Assessment of Marketing Applications Virtual Workshop – 10/30/2020 – 10/30/2020

On This Page Date: October 30, 2020 Time: 9:00 AM – 3:00 PM ET New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing […]
August 26, 2020

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

Submit Comments by 10/26/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
August 26, 2020

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

[ 5-16-2017 ] Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes […]
August 26, 2020

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

Drug Safety Communication (PDF – 58KB) 8-26-2020 FDA Drug Safety Communication Based on a U.S. Food and Drug Administration (FDA) review of new data from three […]
August 26, 2020

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes. For inquiries related […]
August 25, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 25, 2020

For Immediate Release: August 25, 2020 The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: […]
August 25, 2020

Asiaticon SA de CV Issues Voluntary Nationwide Recall of V-Klean Hand Sanitizer Gel, Medically Minded Hand Sanitizer Gel and Protz Real Protection Antibacterial Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

Summary Company Announcement Date: August 25, 2020 FDA Publish Date: August 25, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]
August 25, 2020

Wintac Limited – 606700 – 08/13/2020

Delivery Method: Via Email Reference #: 320-20-43 Product: Drugs Recipient: Recipient Name Dr. Veerappan Subramanian Recipient Title President and CEO Wintac Limited 300 Franklin Square DriveSomerset, […]
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