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 The leading web portal for pharmacy resources, news, education and careers March 23, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 23, 2019

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 163     Next >>     Go To Page:

3/14/19 - BD Announces FDA Premarket Approval For Venovo Venous Stent
WASHINGTON- Becton, Dickinson and Company announced the U.S. FDA has granted premarket approval for the Venovo venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin. We designed the Venovo venous stent in collab
3/14/19 - BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease
BD, a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovo? venous stent, the first stent indicated to treat iliofemoral venous occlusive disease, which is obstructed or narrowed blood flow specific to the iliac and femoral veins located near the groin.
3/14/19 - FDA approves a new generic valsartan [Sudan Tribune]
Today, the U.S. Food and Drug Administration approved a new generic of Diovan. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB
3/14/19 - FDA Approves Neurolixis IND Application for a Clinical Trial with NLX-112 in Parkinson`s Disease [Tehran Times (Iran)]
Preparation and submission of the IND application was supported by funding from Parkinson`s UK, a charity which aims to find a cure and improve life for everyone affected by Parkinson`s through pioneering research, and by providing support services. Dr Arthur Roach, Director of Research at Parkinson`s UK, said: "Dyskinesia is one of the most debili
3/14/19 - FDA approves new generic valsartan to address shortages [Sport360]
The US Food and Drug Administration has approved a new generic valsartan to help relieve recent shortages of the medicine. We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines, said FDA commissioner Scott Go
3/14/19 - New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers... The post New generic valsartan approved to address shortages appeared first on European Pharmaceutical Review.
3/13/19 - Aerie Pharmaceuticals Announces U.S. FDA Approval of Rocklatan 0.02%/0.005% for the Reduction of Intraocular Pressure
DURHAM- Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that the U.S. Food and Drug Administration has approved Rocklatan 0.
3/13/19 - Catalyst OrthoScience Announces 510(k) Clearance for Uncemented Press Fit Humeral Component During the 2019 AAOS Annual Meeting
Catalyst OrthoScience Inc., a medical device company focused on the upper extremity orthopedics market, today announced 510 clearance for its uncemented Press Fit humeral implant. The new humeral component represents the continued evolution of the Catalyst CSR? Total Shoulder System, a disruptive technology introduced in 2016. Samples of the new
3/13/19 - Domp receives Industry Innovation Award from the National Organization for Rare Disorders for the Development of Oxervate? eye drops (cenegermin-bkbj), for neurotrophic keratitis
MILAN and SAN BRUNO, Calif., March 12, 2019/ PRNewswire/ Domp Farmaceutici S.p.A and Domp U.S. Inc.,, announced today that the National Organization for Rare Disorders has awarded them the 2019 Industry Innovation Award for Oxervate. Oxervate ophthalmic solution 0.002% was approved by the U.S. Food and Drug Administration in August 2018 as th
3/13/19 - FDA approves a new generic valsartan
Today, the U.S. Food and Drug Administration approved a new generic of Diovan. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB
3/13/19 - FDA approves new generic version of oft-recalled blood pressure and heart medication [The Miami Herald]
March 13 Mar. 13 The FDA approved a new generic version of valsartan, a blood pressure and heart medication drained into shortage by numerous recalls since July. The FDA said it "prioritized the review of this drug application" to help the recent Valsartan shortage. "When faced with a drug shortage situation, the FDA employs a number of strate
3/13/19 - Laurus gets USFDA nod for drug that treats malaria, auto-immune disease [T-break Tech (Middle East)]
Hyderabad- based Laurus Labs Limited said announced on Monday that it has received a final approval from the US Food and Drug Administration for Hydroxychloroquine tablets 200 mg, which is used for treatment of certain types of Malaria. The drug is a therapeutic equivalent of Plaquenil tablets of Concordia Pharmaceuticals, Inc.. In another developm
3/12/19 - Adlons ADHD treatment approved but with black box warning [Tehran Times (Iran)]
The US Food and Drug Administration approval for Aldon Therapeutics Adhansia XR extended-release capsules comes with a black box warning against possible risks associated with the drug. A spokesperson for Purdue Pharma subsidiary, Adlon, told us that Methylphenidate is a commonly used central nervous system stimulant for the treatment of...
3/12/19 - Aerie Pharmaceuticals Announces U.S. FDA Approval of Rocklatan? (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the Reduction of Intraocular Pressure in Patients with Open-Angle Glaucoma or Ocular Hypertension
Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that the U.S. Food and Drug Administration has approved Rocklatan? 0.02%/
3/12/19 - eNeura, Inc. Receives FDA Clearance for Acute Treatment and Prevention of Migraine in Children 12 Years of Age and Older: eNeura Inc.
2019 MAR 12 By a News Reporter-Staff News Editor at CDC& FDA Daily eNeura, Inc., a privately held medical technology company, announced that it has obtained a new 510 clearance from the U.S. Food and Drug Administration. This new marketing clearance expands the product indication of acute and preventive treatment of migraine to include children
3/12/19 - FDA approves a new generic valsartan
Today, the U.S. Food and Drug Administration approved a new generic of Diovan. The FDA prioritized the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB
3/12/19 - FDA Approves Dupixent (dupilumab) for Moderate-to-severe Atopic Dermatitis in Adolescents
TARRYTOWN, N.Y. and CAMBRIDGE, Mass., March 12, 2019/ PRNewswire/ Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration has approved Dupixent for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescriptio
3/12/19 - FDA grants Roche's Tecentriq in combination with Abraxane accelerated approval for people with PD-L1-positive, metastatic triple-negative breast cancer
Roche today announced that the US Food and Drug Administration has granted accelerated approval to Tecentriq plus chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer in people whose tumours express PD-L1, as determined by an FDA- approved test. The FDA's Accelerated Approval...
3/12/19 - FDA Okays Pfizer's Trastuzumab Biosimilar, Trazimera
NEW YORK CITY- Pfizer Inc. announced the United States Food and Drug Administration has approved Trazimera or trastuzumab-qyyp, a biosimilar to Herceptin or trastuzumab, for the treatment of human epidermal growth factor receptor-2 or HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction...
3/12/19 - First immunotherapy drug to treat breast cancer approved by FDA [New York Daily News]
March 12 Mar. 12 The first-ever immunotherapy treatment for breast cancer has been approved by the Food and Drug Administration. Tecentriq, from Swiss drug company Roche, is designed to treat triple-negative breast cancer, an aggressive disease "with high unmet medical need," according to a release from the brand. "This Tecentriq combination i
3/12/19 - HCA/HealthONE's Presbyterian/St. Luke's is First Hospital in Colorado to Offer Percutaneous Creation of AV Dialysis Fistula Using a Newly-Approved FDA Device
Denver, CO, March 11, 2019 In June 2018, the FDA approved two devices- Ellipsys and WavelinQ- for the percutaneous creation of an arteriovenous anastomosis to create a dialysis fistula. Luke "s Medical Center is the first hospital in Colorado to offer this procedure to patients. The FDA approved devices for the percutaneous creation of an arter
3/12/19 - Laurus Labs receives two approvals from USFDA
Laurus Labs Ltd is pleased to announce that the Company has recently received a final approval from United States Food and Drug Administration for Hydroxychloroquine Tablets 200 mg which is used for treatment of certain type of Malaria. Hydroxychloroquine Tabs 200 Mg is therapeutically equivalent to Plaquenil Tablets 200 mg of Concordia...
3/12/19 - Roche's VENTANA PD-L1 Assay approved as first companion diagnostic to identify triple-negative breast cancer
Roche today announced US Food and Drug Administration approval of the VENTANA PD-L1 Assay2 as the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with the Roche cancer immunotherapy Tecentriq 3 plus chemotherapy. 'Triple-negative breast cancer is an aggressive disease that, until now, h
3/12/19 - Roche's VENTANA PD-L1 Assay Approved As First Companion Diagnostic to Identify Triple-Negative Breast Cancer Patients Eligible for Treatment With Tecentriq in Combination With Abraxane
Roche, a biotech company, issued the following news release:. -This approval is an important step in Roche's personalized healthcare strategy to fit treatments to patients who can benefit most from a specific medicine. Roche today announced US Food and Drug Administration approval of the VENTANA PD-L1 Assay2 as the first companion diagnostic to aid
3/12/19 - ROMEG Therapeutics Receives FDA Approval of GLOPERBA colchicine for Prophylaxis of Adult Gout Flares: ROMEG Therapeutics
2019 MAR 12 By a News Reporter-Staff News Editor at CDC& FDA Daily ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, announced that the U.S. Food and Drug Administration approved GLOPERBA Oral Solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults
Articles(s): 1 - 25 of 163     Next >>     Go To Page:


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