The US Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, produced by Galderma Laboratories, for the topical treatment of the facial erythema (redness) of Rosacea in adults with 18 years or above. With a 12 ...
Tags: Facial Redness, Treatment
ConAgra Foods, in cooperation with the US Food and Drug Administration (FDA), has announced the recall of a limited number of Kroger’s Break ‘N Bake chocolate chip cookie dough products over packaging issue. The US-based ...
Clinical lab instruments developer Magellan Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval to market its LeadCare Ultra blood lead testing system in the US. Claimed to be the first plug-and-play ...
Ceptaris Therapeutics has obtained FDA marketing approval for Valchlor (mechlorethamine) gel to topically treat stage IA and IB mycosis fungoides-type cutaneous T-Cell lymphoma (CTCL) patients who were exposed to skin-directed therapy ...
Tags: Valchlor Gel, Ceptaris
Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system. The system enables surgeons to plan the implant ...
Tags: Shoulder System, Surgical products
Medical devices developer Tissue Regeneration Systems has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its new Cranial Bone Void Filler product designed for repair of neurosurgical burr holes. The new ...
Boston Scientific has received the US Food and Drug Administration (FDA) approval for its IntellaTip MiFi XP catheter and 510(k) clearance for its Zurpaz 8.5F steerable sheath. The IntellaTip MiFi XP is a high resolution catheter that ...
Tags: Cardiac Devices, Drug
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
Denmark-based health care company Novo Nordisk has won US FDA 510(k) clearance for the insulin injection device, NovoPen Echo, combining half-unit dosing with a memory function to help patients manage their diabetes. Available to patients ...
Tags: Insulin Injection, Medicine
PFM Medical, a developer and manufacturer of minimally invasive medical devices for cardio vascular technology, vascular access, surgery, and oncology, has received the US Food and Drug Administration (FDA) premarket approval for its ...
Tags: PFM Medical, Medicine
Israel-based ultrasound technology provider InSightec has received the approval from Health Canada for its ExAblate system designed to treat uterine fibroids and pain palliation of bone metastases non-invasively. The third generation ...
Tags: InSightec, ExAblate System
Second Sight Medical Products has secured Medicare coverage for its Argus II retinal prosthesis system (Argus II) designed to treat the patients affected with blindness from the untreatable orphan disease retinitis pigmentosa in both the US ...
Tags: Government Funding, Medicine
US-based sauces and seasonings manufacturer DennyMike's has unveiled its Sauces and Seasonings Co-Packing facility in Westbrook, Maine. The facility offers co-packing services to small to mid-size producers of shelf stable, dry ingredient ...
Tags: Co-Packing Facility, Sauces
Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...
Tags: FDA Approval, drug application
Integrated global pharmaceutical company Dr. Reddy's Laboratories has introduced divalproex sodium extended - release tablets, USP, in 250mg and 500mg strengths in the US. The new FDA approved product is the generic version of Depakote ER ...