Latest US Food and Drug Administration Stories

OSLO, Norway, February 3 /PRNewswire-FirstCall/ -- - ALSYMPCA Study Designed to Evaluate Alpharadin for the Treatment of Bone Metastases in Prostate Cancer Patients Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces that it is to enroll US patients into its ALSYMPCA phase III trial evaluating Alpharadin as a new treatment for bone metastases in patients with hormone-refractory prostate cancer (HRPC). This decision follows a successful end-of-phase II meeting*...

ATLANTA, Sept. 29 /PRNewswire/ -- As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company , the US Food and Drug Administration (FDA) announced today that it has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The amended rule also includes a broader definition of the populations that could benefit from...

By Berlin, Jesse A Glasser, Susan C; Ellenberg, Susan S Premarketing studies of drugs, although large enough to demonstrate efficacy and detect common adverse events, cannot reliably detect an increased incidence of rare adverse events or events with significant latency. For most drugs, only about 500 to 3000 participants are studied, for relatively short durations, before a drug is marketed. Systems for assessment of postmarketing adverse events include spontaneous reports, computerized...

EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- Novartis announced today that Gleevec(R) (imatinib mesylate) tablets* has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumors (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months(1)....

By Fareed, J Iqbal, O; Cunanan, J; Demir, M; Wahi, R; Clarke, M; Adiguzel, C; Bick, R The conventional management of thrombotic and cardiovascular disorders is based on the use of heparin, oral anticoagulants and aspirin. Despite progress in the sciences, these drugs still remain a challenge and mystery. The development of low molecular weight heparins (LMWHS) and the synthesis of heparinomimetics represent a refined use of heparin. Additional drugs will continue to develop. However, none of...

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the US Food and Drug Administration ("FDA") for the treatment of chronic allograft nephropathy. Chronic allograft nephropathy (CAN), also known as chronic allograft dysfunction, is a fibrotic condition that is a leading cause of kidney transplant failure. Approximately 20% of patients...

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application...

Joyce A. Cramer, President of the Epilepsy Therapy Project (ETP), will be presenting today, Thursday, July 10, 2008, before the US Food and Drug Administration's (FDA) Joint Meeting of the Peripheral and Central Nervous Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee on the incidence of suicidality and correlation to pre-existing psychiatric disorders among patients being treated with anti-epilepsy therapeutics. In her comments, Ms. Cramer will both discuss the...

TUSTIN, Calif., July 7 /PRNewswire-FirstCall/ -- AMDL , a leading vertically integrated bio-pharmaceutical company with operations in China and the US, announced today the US Food and Drug Administration (FDA) has issued a letter of substantial equivalence to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70(R) (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC). According to...

CUPERTINO, Calif., June 30 /PRNewswire-FirstCall/ -- DURECT Corporation announced today that the US Food and Drug Administration (FDA) has granted to DURECT orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia (PHN). Bupivacaine is the active pharmaceutical ingredient in ELADUR(TM), DURECT's investigational transdermal drug patch. If ELADUR is the first bupivacaine product approved for PHN, under the 1983 Orphan Drug Act ELADUR will...