U.S. Food and Drug Administration


Drugs@FDA Data Files

Thu, 17 Aug 2017 14:46:00 -0400

Drugs@FDA Download File (new structure)

Thu, 17 Aug 2017 14:44:00 -0400

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Tue, 15 Aug 2017 16:47:00 -0400

Medication Guides

Thu, 10 Aug 2017 11:09:00 -0400

Newly Added Guidance Documents

Tue, 08 Aug 2017 07:50:00 -0400

FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)

Fri, 04 Aug 2017 14:08:00 -0400

FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor

Fri, 04 Aug 2017 13:54:00 -0400

FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets

Fri, 04 Aug 2017 11:56:00 -0400

FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules

Fri, 04 Aug 2017 11:32:00 -0400

FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone

Fri, 04 Aug 2017 11:06:00 -0400

FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs--Angiotensin Receptor Blockers (ARBs)

Fri, 04 Aug 2017 11:02:00 -0400

FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer

Fri, 04 Aug 2017 11:01:00 -0400