FDA News and Approvals

FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
Sensus Healthcare Receives FDA Clearance to Treat Keloids with the SRT-100™

BOCA RATON, Fla., May 24, 2013 /PRNewswire/ -- Sensus Healthcare is pleased to announce that it has received clearance from the U.S. Food and Drug Administration to treat Keloids with the SRT-100™. The SRT-100™ is the leading alternative to surgery in treating Non...
For breast cancer patients seeking a natural reconstruction, HydraSolve® liposuction from Andrew Technologies offers the first FDA-cleared option to provide your own fat for transfer
IRVINE, Calif., May 24, 2013 /PRNewswire/ -- Andrew Technologies applauds the courage of actress Angelina Jolie and reporter Zoraida Sambolin of CNN to go public about their own personal experiences with breast cancer. This terrible disease has devastated the lives of many women and...
Communiqué de presse au nom de la famille Singh (les anciens actionnaires et fondateurs de Ranbaxy)
GURGAON, Inde, May 24, 2013 /PRNewswire/ -- Le 22 mai 2013, la société Daiichi Sankyo a publié un communiqué de presse indiquant notamment qu'elle « [estimait] que certains anciens actionnaires de Ranbaxy [avaient] dissimulé et falsifié des...
Pressemitteilung im Namen der Familie Singh (ehemalige Aktionäre und Gründer von Ranbaxy)
GURGAON, Indien, May 24, 2013 /PRNewswire/ -- Am 22. Mai 2013 veröffentlichte Daiichi Sankyo eine Pressemitteilung, in der das Unternehmen unter anderem erklärte, es "glaube, dass gewisse ehemalige Aktionäre von Ranbaxy entscheidende Informationen über die...
Declaración a la prensa en nombre de la familia Singh (antiguos accionistas y fundadores de Ranbaxy)
GURGAON, La India, May 24, 2013 /PRNewswire/ -- El 22 de mayo de 2013, Daiichi Sankyo publicó una declaración en la prensa en la que, entre otras cosas, se indicó que "creía que algunos accionistas antiguos de Ranbaxy ocultaron y representaron de forma errónea...
FDA allows marketing of first A1c test labeled for diagnosing diabetes
Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use.
Press Statement on Behalf of the Singh Family (The Former Shareholders and Founders of Ranbaxy)
GURGAON, India, May 23, 2013 /PRNewswire/ -- On 22 May 2013, Daiichi Sankyo released a press statement where, among other things, it was stated that it "believes that certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US DOJ and FDA...
BioElectronics and Pulsed Shortwave Therapy Make Progress
FREDERICK, Md., May 23, 2013 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of very effective, safe consumer medical devices, comments on the FDA panel meeting for non-thermal shortwave diathermy: The FDA's Public Advisory Panel Reclassification –...
Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease
SEATTLE, May 23, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits...
Varian Medical Systems Receives FDA 510(k) Clearance of its Nexus DRF Digital X-Ray Imaging System
SALT LAKE CITY, May 22, 2013 /PRNewswire/ -- Varian Medical Systems (NYSE:VAR) today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Varian's diagnostic X-ray image processing workstation that combines radio frequency (RF) and digital...
Bausch + Lomb Receives FDA Approval for the TRULIGN™ Toric Posterior Chamber Intraocular Lens
ALISO VIEJO, Calif., May 21, 2013 /PRNewswire/ -- Bausch + Lomb, the global eye health company, today announced that it is has received approval from the U.S. Food and Drug Administration (FDA) for the TRULIGN™ Toric posterior chamber intraocular lens (IOL)....
BioElectronics Presents FDA Reclassification Panel
FREDERICK, Md., May 21, 2013 /PRNewswire/ -- BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free consumer electronic devices, announced that CEO, Andrew J. Whelan is presenting today to the FDA's Medical Advisory Committee, Orthopedic and Rehabilitation...
Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening
BEDFORD, Mass., May 21, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today...
Muscle Warfare a wholly owned subsidiary of Embark Holdings (EMBK) passes inspection by the FDA
WELLINGTON, Fla., May 20, 2013 /PRNewswire/ -- Embark Holdings, Inc. (OTC: EMBK) announces that its wholly owned subsidiary Muscle Warfare, Inc. has passed a recent FDA inspection entitled an EIR (Establishment Inspection Report). The inspection was conducted to confirm that Muscle...
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.
New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy
ORLANDO, Fla., May 18, 2013 /PRNewswire/ -- Although colonoscopy exams prevent many colon cancer deaths1 and are considered the most sensitive method for detecting colorectal cancers2, the procedure is not completely effective in preventing cancer cases3. EndoChoice® Inc. today...
FDA seeks preliminary injunction against New York fish manufacturer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.
FDA Sets 17 July 2013 For MOXDUO® Advisory Committee Meeting
SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company's resubmitted MOXDUO New Drug...
Thoratec Announces FDA Approval Of HeartMate II® Pocket Controller™
PLEASANTON, Calif., May 17, 2013 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it has received approval from the U.S. Food and Drug...
Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
JERUSALEM, May 17, 2013 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug...
Mylan Launches Generic Tricor® Tablets
PITTSBURGH, May 17, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its...
Syneron Introduces Enhancements to its Innovative Body Shaping Products

YOKNEAM, Israel, May 16, 2013 /PRNewswire/ -- Expands treatment capabilities, reduces treatment time, and improves overall experience with UltraShape and VelaShape systems Syneron Medical Ltd. (NASDAQ:ELOS), the leading global aesthetic device company, announced today the...
Syneron presenta mejoras dentro de sus innovadores productos de remodelación corporal

YOKNEAM, Israel, May 16, 2013 /PRNewswire/ -- Amplía las opciones de tratamiento, reduce el tiempo de la sesión y mejora la experiencia general con los sistemas UltraShape y VelaShape Syneron Medical Ltd. (NASDAQ:ELOS), principal compañía global de equipos medico-...
FDA approves Simponi to treat ulcerative colitis
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
FDA approves new drug for advanced prostate cancer
The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).
FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients
On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.
FDA releases new tool to help prevent intentional food contamination
The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.
FDA warns consumers about potential health risk with Juices Incorporated juice products
The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.
FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop
The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
FDA issues proposal to increase consumer awareness of tanning bed risks
Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
FDA warns pregnant women to not use certain migraine prevention medicines
The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
FDA approves Procysbi for rare genetic condition
The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.
FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding
The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.
FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool
The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.
FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy
Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.
FDA approves abuse-deterrent labeling for reformulated OxyContin
The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).

Login Form