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 The leading web portal for pharmacy resources, news, education and careers December 15, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 15, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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12/15/18 - Dr. Jin Kim, Internationally Influential Periodontist, Offers FDA-Cleared LANAP Laser Therapy for Periodontal Disease in Chino Hills, CA [Tehran Times (Iran)]
-Jin Y. Kim, a leading board-certified periodontist who has dedicated his career to learning and contributing to the latest in periodontal care welcomes people withperiodontal diseasein Chino Hills, CA, to take advantage of LANAP, the FDA- cleared laser gum therapy treatment he offers. When patients work with Dr. Kim to properly address their gum d
12/15/18 - Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR Label to Include Monotherapy [Sport360]
-Supernus Pharmaceuticals, Inc. announced today that the United States Food and Drug Administration has approved the Companys supplemental new drug application for Oxtellar XR. We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR, said Jack Khattar, president and chief executive
12/14/18 - EhmetDx Receives FDA Approval Letter for X-Ray CBCT 510(k) Submission
EhmetDx announced today that the company has received 510 clearance from the U.S. Food and Drug Administration for its innovative 3 D CBCT positioning software to be used in patient treatment at the McLaren Proton Therapy Center. Michael Teicher, Founder and CEO states, "We look forward toward patient treatment using our software for positioning
12/14/18 - FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia
Amgen today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Nplate for the treatment of pediatric patients one year of age and older with immune thrombocytopenia for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
12/14/18 - Federal Register Extracts
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns exp
12/14/18 - Janssen Submits Supplemental New Drug Application (sNDA) to FDA for XARELTO (rivaroxaban) to Prevent Venous Thromboembolism (VTE) in Acute Medically Ill Patients
The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the submission of a supplemental New Drug Application for XARELTO to the U.S. Food and Drug Administration for the prevention of venous thromboembolism, or blood clots, in medically ill patients. "Despite being at high risk of VTE for up to six weeks when leaving the hos
12/14/18 - Mayne Pharma receives FDA approval of Tolsura (SUBA-itraconazole capsules) for the treatment of certain fungal infections [T-break Tech (Middle East)]
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration has approved the New Drug Application for Tolsura 65 mg capsules. Mayne Pharma`s CEO, Mr Scott Richards said, "We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma`s proprietary SUBA te
12/14/18 - Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR Label to Include Monotherapy
Supernus Pharmaceuticals, Inc. announced today that the United States Food and Drug Administration has approved the Company s supplemental new drug application for Oxtellar XR . We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR, said Jack Khattar, president and chie
12/14/18 - Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing the withdrawal of the proposed rule on "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns exp
12/13/18 - Bausch + Lomb Receives 510K Clearance From FDA For Bausch + Lomb Ultra Multifocal For Astigmatism Contact Lenses
By a News Reporter-Staff News Editor at Health& Medicine Week Bausch+ Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc., announced that it has received 510 clearance from the U.S. Food and Drug Administration for Bausch+ Lomb ULTRA Multifocal for Astigmatism contact lenses, the first multifoc
12/13/18 - Contego Medical Receives 510k Clearance for the Vanguard IEP Peripheral Angioplasty System with Integrated Embolic Protection
By a News Reporter-Staff News Editor at Cardiovascular Week Contego Medical announced that the U.S. Food and Drug Administration has granted 510 clearance for its Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection. Contego Medical is a medical device company developing and commercializing a suite of...
12/13/18 - FDA Clears First Daily Disposable Silicone Hydrogel Contact Lens Coated with Modified Formula of Tangible Hydra-PEG
Tangible? Science, LLC, an innovator creating a dramatically better contact lens experience for patients and eye care practices, announced that the U.S. Food and Drug Administration has cleared the first daily disposable silicone hydrogel contact lens coated with a modified formula of Tangible? Hydra-PEG?. Tangible Hydra-PEG is an innovative
12/13/18 - FDA clears Pear/Sandoz app for opioid use disorder [Kuwait News Agency]
A second mobile app developed by Pear Therapeutics to help opioid use disorder patients who have a more successful response to therapy has been given a green light by the FDA. It is the first drug-paired app to be approved by the FDA. reSET-O has been approved by the FDA on the strength of a 170- patient trial which examined the effects of adding u
12/13/18 - Mylan Expands Gastroenterology Portfolio with Launch of Generic for Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets
By a News Reporter-Staff News Editor at Drug Week Global pharmaceutical company Mylan N.V. announced the U.S. launch of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg, a generic version of Takeda's Prevacid SoluTab DR ODT. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration for
12/13/18 - QUBYX Receives FDA Clearance for DICOM Calibration Tool and a Dell UP3017 Monitor
Wilmington, DE, December 13, 2018 QUBYX Software Technologies Inc., a company developing high end software solutions for medical imaging and color management industries, received FDA clearance for its DICOM calibration tool and a Dell UP3017 monitor to be used for viewing medical images such as MRI, CT, X- ray, ultrasound, and others, as well a
12/13/18 - Virtus Announces FDA Approval of its AB Rated Generic Levorphanol Tartrate 2mg Tablets CII
Virtus Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Levorphanol Tartrate 2 mg immediate release tablets. The company is preparing for launch to the mar
12/12/18 - AMRA Receives U.S. FDA Clearance for AMRA(R) Profiler, a Magnetic Resonance Diagnostic Software ... [ITWeb]
AMRA Medical, the international leader in body composition analysis, announced today that it has received FDA clearance for AMRA Profiler, now available for use in a clinical setting in the US. "We are delighted with the FDA's decision. Cost constraints, together with societal issues such as obesity and an aging population, are putting hospital
12/12/18 - Cadila Healthcare subsidiary gets USFDA nod for ulcer treatment injection [Sudan Tribune]
Drug firm Cadila Healthcare Tuesday said its subsidiary has received approval from the US health regulator to market Ranitidine injection, used to treat stomach and duodenal ulcers. Liva Pharmaceuticals, a wholly-owned subsidiary of Cadila Healthcare, has received approval from the US Food and Drug Administration for its supplemental abbreviated ne
12/12/18 - Cerenovus Launches Largest Global Registry to Study Stroke-Inducing Blood Clots Removed by Thrombectomy
The EXCELLENT Registry will enroll up to 1,000 ischemic stroke patients in as many as 50 clinical sites in the United States and Europe. The device was cleared by the FDA in the U.S. earlier this year and has been available in Europe since 2016.. The company received CE mark approval in the European Union for the device earlier this month and is co
12/12/18 - FDA Approves BRACAnalysis CDx as a Companion Diagnostic for Pfizer's Talzenna
The agency's approval will permit healthcare professionals to use BRACAnalysis CDx testing to identify patients with HER2-negative metastatic breast cancer who are eligible for treatment with Talzenna.
12/12/18 - FDA approves first prescription mobile app for opioid use disorder, courtesy of Sandoz and Pear Therapeutics [Sudan Tribune]
A digital therapeutic launched by Pear Therapeutics and Novartis generics and biosimilars division Sandoz has become the first FDA- approved app of its kind for use in the treatment of opioid use disorder, it has emerged. "Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help i
12/12/18 - FDA Clears Calprotectin Extraction Device
The first such device to receive FDA clearance, Inova's fecal extraction device provides significant workflow improvement to the laboratory.
12/12/18 - Mayne Pharma Receives FDA Approval of Tolsura for the Treatment of Certain Fungal Infections
Mayne Pharma Group, a branded and generic pharmaceuticals company, issued the following news release:. Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration has approved the New Drug Application for Tolsura (TM) 65 mg capsules. Mayne Pharma's CEO, Mr Scott Richards said "We are very pleased to have received FDA
12/12/18 - SunGen Pharma Receives Its Second and Third ANDA Approval from US FDA [Sudan Tribune]
-SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced it has received its second and third ANDA approval from the US Food and Drug Administration. Amphetamine Salts had total U.S. sales of $364 million for the twelve months ending Septembe
12/11/18 - Achaogen Announces FDA Clearance and Launch of the Thermo Scientific QMS Plazomicin Immunoassay
SOUTH SAN FRANCISCO- Achaogen, Inc., a biopharmaceutical company discovering, developing and commercializing innovative antibacterial agents to address multi-drug resistant gram-negative infections, today announced that the Center for Devices and Radiological Health of the U.S. Food and Drug Administration has provided clearance for the Thermo...
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