AMNEAL PHARMACEUTICALS: Announces Approval of Generic Version of Amicar®
Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway
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Doctors see good things with new scoliosis treatment recently approved by FDA
A doctor based at Johns Hopkins in Baltimore sees the new treatment for scoliosis recently approved by the U.S. Food and Drug Administration as a viable option for young patients.
Drawbridge Health's new blood collection device receives 510(k) clearance
Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.
Super antioxidant Ergothioneine achieves GRAS status
The super antioxidant called ergothioneine or ErgoActive by ingredient supplier and manufacturer Blue California has achieved Generally Recognized as Safe (GRAS) status from the Food and Drug Administration (FDA) under its intended conditions of use.
FDA approves new treatment for scoliosis
The U.S. Food and Drug Administration approved an innovative treatment for scoliosis last week and it happens to have a fancy nickname. It’s called The Tether and it provides a fusion-less alternative for young patients requiring surgery.
AKORN: Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.15%
Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray, 0.15%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.
KYOWA KIRIN CO., LTD.: Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease
First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S.
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US WORLDMEDS: FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea
MYOBLOC is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as one week(1),(2)
Eylea Injection Prefilled Syringe approved by FDA
The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.
Islaroxime receives FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.
MCKESSON: ROZLYTREK™ (entrectinib), FDA Approved for Hard-to-Treat NTRK Fusion-Positive Tumors, Available at Biologics by McKesson
Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by Genentech as a specialty pharmacy provider for ROZLYTREK™ (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumor
NABRIA THERAPEUTICS: Receives U.S. FDA Approval of Xenleta™ (lefamulin) to Treat Community-Acquired Bacteria Pneumonia (CABP)
Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations of Xenleta™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
CELGENE CORPORATION: U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis
INREBIC provides new, once-daily oral option for patients affected by rare bone marrow cancer
CVRX, INC.: CVRx Receives FDA Approval for World's First Heart Failure Neuromodulation Device
BAROSTIM™ NEO provides significant clinical benefit to heart failure patients
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new device to improve symptoms in patients with advanced heart failure
The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
FDA also approves drug for second indication in a type of lung cancer
FDA Update: generic drug approvals
The U.S. Food and Drug Administration periodically provides information on the pace of generic drug approvals through its website.