Drug approved for seizures related to tuberous sclerosis complex
Aug 4 - Treatment for patients one year of age and older
Drugs
The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
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CDER is engaged in essential COVID-19 activities to protect and promote public health
Ranging from the acceleration of development for treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to manufacturers, advising developers on how to handle clinical trial issues, and keeping the public informed
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Consumers and Patients
FAQs about hand sanitizers. Find drug information. Report drug side effects. Learn how to buy, use, and dispose of unused drugs. Attend a public meeting.
Health Care Professionals
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Industry
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Drug Safety Announcements
Aug 03
FDA updates on hand sanitizers consumers should not use
Jul 23
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
Jul 17
Compounding Quality Center of Excellence: Virtual, Interactive Training Programs
Center
Drug-related Recall Announcements
Aug 05
Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency
Aug 04
Roque Plast S.A. de C.V. Issues Voluntary Nationwide Recall of Command Brands Gel AntiBac Instant Hand Sanitizer Lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 Due to Potential Presence of Methanol (Wood Alcohol)
Jul 31
LABORATORIOS JALOMA S.A. de C.V. Issues Voluntary Recall of the Jaloma Antiseptic Hand Sanitizer Due to the Potential Presence of Undeclared Methanol
Center
Drug-related Press Announcements
Jul 31
FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
Jul 27
Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
CENTER FOR DRUG EVALUATION AND RESEARCH
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