USFDA

- Read more about Clovis Oncology Rociletinib NDA scheduled for presentation at upcoming FDA ODAC
Clovis Oncology, Inc. announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12, 2016.
- Read more about Optovue’s AngioVue imaging system receives FDA clearance
Optovue announced FDA clearance and immediate U.S. commercial availability of the AngioVue™ Imaging System, a groundbreaking technology that provides a non-invasive way to visualize abnormal blood vessels in the retina to help physicians determine an appropriate course of treatment.
- Read more about Guerbet receives FDA 510k clearance for the OptiOne™ single-head contrast delivery system
Guerbet announced that it has received 510K clearance from the US Food and Drug Agency (FDA) for its OptiOne™ Single-Head Contrast Delivery System, featuring advanced multi-purpose functionality for CT imaging procedures.
- Read more about RedHill Biopharma announces successful PK study With BEKINDA™ 12 mg and submission to FDA of IBS-D Phase II study Protocol
RedHill Biopharma Ltd, announced the successful completion of a first-in-man pharmacokinetic (PK) study of BEKINDA™ 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill further announced the submission to the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) protocol for the Phase II clinical study with BEKINDA™ 12 mg for IBS-D, planned to be initiated in the coming weeks, subject to final preparations.
- Read more about Cellceutix will submit SPA to FDA for phase 3 for treatment of ABSSSI
Cellceutix Corporation will be submitting a Special Protocol Assessment (SPA) request for phase 3 clinical research of its novel single-dose antibiotic, Brilacidin, for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI) caused by Gram-positive bacteria. The Company anticipates submission of the SPA request to the U.S. Food and Drug Administration (FDA) within two weeks.
- Read more about FDA Grants Priority Review to KemPharm for KP201/APAP NDA
KemPharm, Inc. announced that the New Drug Application (NDA) for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA). In addition, the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
- Read more about Aurobindo Pharma receives USFDA approval for Levofloxacin in Dextrose Injection
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin® (Levaquin in 5 % Dextrose) by Janssen Pharmaceuticals, Inc.
- Read more about Diabetic drug may help treat cocaine addiction
Researchers have found that a US Food and Drug Administration (FDA)-approved drug currently used for obese patients and Type-2 diabetics has the potential to be used in the treatment of cocaine dependence.
- Read more about Pfizer commends the FDA advisory committee’s vote to approve proposed Biosimilar Infliximab
Pfizer Inc. commends recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three.
- Read more about Spectranetics get FDA 510(k) clearance for bridge™ Occlusion Balloon
Spectranetics Corporation announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) clearance of the Bridge Occlusion Balloon for temporary vessel occlusion in cardiac lead extraction procedures.