StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system. ...
Tags: Stelkast, Total Knee System
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
Therapeutic devices developer Abyrx has received 510(k) approval from the US Food and Drug Administration (FDA) for its new resorbable hemostatic bone putty called Hemasorb Plus that achieves hemostasis by mechanical tamponade. Hemasorb ...
CSL Behring has received approval from the US Food and Drug Administration (FDA) for a new 10g (50mL) vial size of Hizentra, an immune globulin subcutaneous (human) liquid drug. Hizentra, which is claimed to the first and only 20% ...
Tags: CSL Behring, Hizentra
The US Food and Drug Administration (FDA) has approved the third drug to be offered in the new BD Simplist line of ready-to-administer prefilled generic injectables. The third BD Simplist product to be introduced includes Ondansetron ...
Octapharma USA, part of Swiss human protein products maker Octapharma Group, has announced the availability of Octaplas, a solvent/detergent treated pooled human plasma, in the country. Designed to reduce the risk of pathogen transmission ...
Tags: protein products, Octapharma
Advanced Bionics has obtained the US Food and Drug Administration (FDA) approval for its new Naída CI Q70 (Naída CI) sound processor which is now commercially available in the US. Advanced Bionics in collaboration with ...
Tags: Advanced Bionics, Sound Processor
Fresenius Kabi USA has announced the availability of Levofloxacin in 5% dextrose injection in freeflex containers. Freeflex is a PVC-free, plasticizer-free, non-DEHP container, which is designed for easy handling and infusing the ...
Tags: Fresenius Kabi, Freeflex Container
SpineGuard has received 510(k) clearance from the US Food and Drug Administration (FDA) for three new products, designed to enhance pedicle screw penetration of small and/or difficult-to-access pedicles. The two miniaturized versions of ...
Tags: Pediguard Products, SpineGuard
The US Food and Drug Administration (FDA) has issued Breakthrough Therapy Designation for Catalyst Pharmaceutical Partners’ Firdapse (amifampridine phosphate), which is used to treat patients with Lambert-Eaton Myasthenic Syndrome ...
Tags: Therapy Designation, Medicine
Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US. The Mobi-C is designed for ...
Tags: Medical device, LDR
InControl Medical has launched InTone, a non-surgical and no-drug solution designed for effective, non-invasive treatment of female urinary incontinence. InTone which is listed as a class II medical device by the US Food and Drug ...
Tags: InControl Medical, launched InTone
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 ...