FDA Approvals & Clearances
Track new drug approvals and medical device clearances from the FDA.
Recent Drug Approvals
View all →Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangan
Annora Pharma Private Limited
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC
Amgen, Inc.
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC
Amgen, Inc.
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Appli
CareFusion 213, LLC
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Aja
Ajanta Pharma USA Inc
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand O
Amgen, Inc.
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Bea
Elevate Oral Care
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distr
Direct Rx
Recent 510(k) Clearances
View all →MIST IC
Imagine Milling Technologies, LLC
BraiN20® (BraiN20)
Time IS Brain, S.L.
SOMNUM (SOMNUM)
Honeynaps Co., Ltd.
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
BioHorizons Implant Systems, Inc.
VERTICALE® Navigation Instruments
Silony Medical GmbH
PhAST instrument and PhAST Blood Culture Gram-negative Panel
Phast Corp.
i-STAT Crea cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
LightningWire Transseptal Puncture System (TPS)
ElectroWire Medical