FDA News and Approvals

Ascension Orthopedics Receives FDA Approval for TITAN™ Modular Total Shoulder System
AUSTIN, Texas, Sept. 2 /PRNewswire/ -- Ascension Orthopedics, Inc., the world leader in PyroCarbon orthopedic devices, announces FDA approval to market the TITAN™ Modular Total Shoulder System. This newly designed system redefines modularity by providing multiple surgical solutions for shoulde
Actavis Receives FDA Approval of Atomoxetine HCl Capsules
MORRISTOWN, N.J., Sept. 1 /PRNewswire/ -- Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD). Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 m
Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
DES PLAINES, Ill., Sept. 1 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the
Unilife Corporation Secures FDA 510k Clearance for the Unitract™ 1mL Tuberculin Syringe
LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA). The Unitract&
InfraReDx Receives FDA Clearance for LipiScan™ IVUS Coronary Imaging System
BURLINGTON, Mass., Sept. 1 /PRNewswire/ -- InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the LipiScan™ IV
Biodel Announces Name Change for Lead Product Candidate
DANBURY, Conn., Sept. 1 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) announced today that Linjeta™ (pronounced lin-JET-uh) will replace VIAject as the proposed trade name for Biodel's most advanced product candidate. The change follows FDA's review and acceptance of Linjeta
FDA seeks court order against Michigan dairy
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues.
FDA launches new organizational performance management system
The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.
MonoSol Rx Announces Reckitt Benckiser FDA Approval of Suboxone® Sublingual Film for Treatment of Opioid Dependence
WARREN, N.J., Aug. 31 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc
GSK and Valeant Announce New U.S. FDA PDUFA Goal Date for Ezogabine
LONDON, RESEARCH TRIANGLE PARK, N.C., and ALISO VIEJO, Calif., Aug. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal
Bionovo Receives Positive Guidance from FDA on Menerba®
EMERYVILLE, Calif., Aug. 30 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Mener
BioMarin Receives Orphan Drug Designation from the FDA for BMN-701 for the Treatment of Pompe Disease
NOVATO, Calif., Aug. 30 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in
NPA Advocates for Dietary Supplement Industry to the U.S. Supreme Court
Files Brief Urging Proper Role for AERs WASHINGTON, Aug. 27 /PRNewswire-USNewswire/ -- Today the Natural Products Association (NPA) is filing an amicus curiae brief in the U.S. Supreme Court defending the dietary supplement industry against an overreaching and potentially damaging decision by the Ni
Novartis receives FDA approval of Tekamlo™, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
EAST HANOVER, N.J., Aug. 27 /PRNewswire/ -- The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely use
Gold Standard/Elsevier First to Launch State, Federal Controlled Substance Drug Schedules, Helping Ensure Safe, Compliant Prescribing and Dispensing
TAMPA, Florida, August 27, 2010 /PRNewswire/ -- - New Alchemy Module Allows Healthcare Providers to Verify and Comply With State and Federal Prescription Drug Regulations Gold Standard/Elsevier, developer of drug databases and medication management solutions, announced today the availa
Endologix Receives CE Mark Approval for Expanded Line of Powerlink Products and PowerFit Aortic Extensions
IRVINE, Calif., Aug. 26 /PRNewswire-FirstCall/ -- Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic
FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers
SWIFTWATER, Pa., Aug. 26 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra&#
FDA Warns Consumers to Avoid TimeOut Capsules
The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.
Actelion Pharmaceuticals Announces FDA Approval of Brand Name for Commercially Available VELETRI® (epoprostenol for injection) for Pulmonary Arterial Hypertension
SOUTH SAN FRANCISCO, Calif., Aug. 25 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved the brand name VELETRI® for the company's epoprostenol for injection therapy. VELETRI has been commercially available since
Medyssey Spine Receives FDA 510(k) Clearance for Zenius(TM) Thoracolumbar Spinal System in Titanium Alloy (Ti6AL-4V ELI)
LOS ANGELES, Aug. 25 /PRNewswire/ -- South Korea-based Medyssey Co., Ltd. announced today that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launc
Perrigo Receives FDA Clearance to Manufacture New Infant Formula Liquid Concentrate and Ready-to-Use Products
ALLEGAN, Mich., Aug. 25 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced it received FDA clearance on August 23, 2010 to manufacture infant formula liquid concentrate and ready-to-use products through its partner Kerry Proteins and Nutritionals located in Sainte Claire, Quebe
FDA releases guidance on federal menu labeling requirements
The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.
FDA Warns of Possible Dangers from Portable Foot-Tanning Device
The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.
Pentasa(R) - Shire Receives Ruling From FDA on Citizen's Petition
DUBLIN and PHILADELPHIA, August 24, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition relating to Pentasa. The
PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.
NES-ZIONA, Israel, Aug. 24 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical
Study: Presence of murine leukemia virus found in CFS Patients, others
Researchers have found murine leukemia viruses (MLV) in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).
Urgent Nationwide Frozen Mamey Fruit Products Recall
An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.
Urgent Nationwide Egg Recall
The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.
U.S. Marshals seize food from rodent-infested Ga. warehouse
U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.
FDA Proposes Withdrawal of Low Blood Pressure Drug
The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
FDA approves ella™ tablets for prescription emergency contraception
The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal
The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.
FDA: Salmonella risk from frozen rodents fed to reptiles
The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice, rats and chicks from Biggers and Callaham LLC, dba/MiceDirect.com, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella.
FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.
FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.
Statement by Margaret A. Hamburg, Commissioner of Food and Drugs on the Reopening of Florida State Waters to Commercial Fishing
We are pleased to be able to support the state of Florida as it reopens state waters off Pensacola to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish that will be coming out of this area.
Statement by Margaret A. Hamburg, Commissioner of Food and Drugs, on the Reopening of Some Mississippi State Waters to Commercial Fishing
We are pleased to be able to support the state of Mississippi as it reopens state waters in the Mississippi Sound, from the mainland to the barrier islands, to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish and shrimp that will be coming out of this area.”
United States Seeks Permanent Injunction Against New York Food Processor
The U.S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against NY Gourmet Salads, Inc., a processor of ready-to-eat deli salads, seafood salads, and cream cheeses in Brooklyn, N.Y., and Leonard F. Spada, the company's president. (HR)
FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.
FDA Approves Vaccines for the 2010-2011 Influenza Season
The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.

* Your email address:
* Preferred Format:
* Enter the security code shown:

Get Free Email and Phone News Alerts