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 The leading web portal for pharmacy resources, news, education and careers January 27, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 27, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 62     Next >>     Go To Page:

1/27/15 - Baxter Gets FDA Approval for PHOXILLUM Solution [Professional Services Close - Up]
Baxter International reported that the United States Food and Drug Administration has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.
1/27/15 - Chipscreen Biosciences Announces CFDA Approval of Chidamide Epidaza for PTCLs in China
By a News Reporter-Staff News Editor at China Weekly News Chipscreen Biosciences announced regulatory approval of Chidamide, the world first orally administrated and subtype-selective histone deacetylase inhibitor for relapsed or refractory peripheral T-cell lymphoma patients, in China on Dec. 23, 2014 by the Chinese Food and Drug Administration.
1/27/15 - FDA approves first generic esomeprazole
Release date- 26012015- The U.S. Food and Drug Administration today approved the first generic version of Nexium to treat gastroesophageal reflux disease in adults and children ages 1 and older. Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules.
1/27/15 - Novo Nordisk Receives FDA Approval for Norditropin FlexPro 30 mg/3.0 mL for Patients with Growth Hormone Disorders
Novo Nordisk announced today the U.S. Food and Drug Administration approval of Norditropin FlexPro 30 mg/3. 0 mL, a prefilled injection pen for patients with growth hormone-related disorders. "Novo Nordisk is committed to advancing growth hormone delivery devices with patients in mind," said Eddie Williams, senior vice president, Biopharma
1/27/15 - ONCOLIX, INC. Announces Capital Raise of $4.2 Million
ONCOLIX, INC., announced today that it has completed a Series A round of financing, led by PoC Capital, LLC and Integrium Clinical Research, LLC. Also participating in the finance round was the Texas Emerging Technology Fund and certain healthcare-focused investors, representing gross proceeds to ONCOLIX of approximately $4.2 million. The FDA has
1/27/15 - PFE Cuts Vaccine Price, CVM On Track, BABY Takes New Step, IPXL On A High
NEW YORK CITY- CEL-SCI Corp. is all set to expand its phase III trial of investigational therapy Multikine, developed as a potential first-line treatment for advanced primary head and neck cancer, into Romania. Impax Laboratories Inc. has received FDA approval for generic Lamictal Orally Disintegrating Tablets, of strengths 25 mg, 50 mg, 100 mg and
1/27/15 - Shire's NPS deal validated as US approves drugs
SHIRE'S $5.2 bn takeover of NPS Pharmaceuticals just weeks ago is already paying off. The US Food and Drug Administration approved Natpara to treat a rare hormone disorder, hypoparathyroidism. In clinical studies, Natpara has been shown to increase serum calcium levels and reduce the need for large doses of calcium and active vitamin D, "said NPS p
1/26/15 - EnteroMedics Announces FDA Approval of VBLOC Vagal Blocking Therapy for the Treatment of Obesity
By a News Reporter-Staff News Editor at Clinical Trials Week EnteroMedics Inc. announced that the U.S. Food and Drug Administration has approved VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39
1/26/15 - EOS imaging Receives FDA Clearance for Micro Dose
EOS imaging, the pioneer in orthopedic 2 D/3D imaging, announced today that the U.S. Food and Drug Administration has cleared the Micro Dose feature for pediatric imaging. Initial results presented at the 2013 French Society of Radiology Annual Meeting and during the 2014 Annual Meeting of the Radiological Society of North America 2, 3 concluded th
1/26/15 - FDA approves a second vaccine to prevent serogroup B meningococcal disease
Release date- 23012015- The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Bexsero is the second vaccine approved by the FDA in the past three months to prevent this disease. 'With today's approval o
1/26/15 - FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share
DexCom, Inc.,, a leader in continuous glucose monitoring for patients with diabetes, announced today that it has received U.S. Food and Drug Administration approval for its Dexcom G4 PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy between a patient
1/26/15 - FDA Approves Pulmozyme with eRapid Nebulizer; CF Patients See 2 - 3 Minute Treatment Times
The eRapid Nebulizer System from PARI has been approved as the first electronic nebulizer by the Food and Drug Administration to deliver Genentech's Pulmozyme for cystic fibrosis treatment. As the first electronic nebulizer to deliver Pulmozyme, eRapid is a true breakthrough for cystic fibrosis patients who take the therapy daily, often for years
1/26/15 - Impax Receives FDA Approval for a Generic Version of Lamictal Orally Disintegrating Tablets (ODT)
Impax Laboratories, Inc. announced today that the U.S. Food and Drug Administration has approved generic Lamictal Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division. In July 2014, Impax acquired
1/26/15 - Impax: FDA Approves Generic Lamictal ODT Antiepileptic Drug
WASHINGTON- Impax Laboratories Inc. announced the U.S. Impax said it will promptly initiate commercialization of the product through Global Pharmaceuticals, Impax's generic division. In July 2014, Impax acquired from Actavis plc the approved Abbreviated New Drug Application for generic lamotrigine ODT packaged in bottles pursuant to an Asset Purcha
1/26/15 - Medtronic Introduces Enhanced Therapy to Treat Debilitating Symptoms of Serious Stomach Disorder
ENP Newswire- 25 January 2015. Release date- 23012015- MINNEAPOLIS Medtronic, Inc. today announced it has received United States Food and Drug Administration approval, under a humanitarian device exemption*, for the Medtronic Enterra II System. The system is used to treat chronic, intractable nausea and vomiting associated with gastroparesis of d
1/26/15 - Milestone Pharmaceuticals Receives FDA Clearance of MSP-2017 Phase 2 IND
By a News Reporter-Staff News Editor at Clinical Trials Week Milestone Pharmaceuticals, Inc. announced that it received clearance of its Investigational New Drug Application from the U.S. Food and Drug Administration to conduct a Phase 2 study of MSP-2017 for the treatment of acute episodes of Paroxysmal Supraventricular Tachycardia.
1/26/15 - New Drug Approvals - The Month That Was
Some drugs pass the FDA muster easily, while some face a host of hurdles before getting the official stamp of approval. The FDA approved 41 novel new drugs last year, compared to 27 in 2013, and perhaps the most in nearly 20 years. Developed by Tokyo- based Daiichi Sankyo Co. Ltd., Savaysa was approved by the FDA on January 8, 2015.
1/26/15 - Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US
Release date- 23012015- Basel,- Novartis announced today that the US Food and Drug Administration has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10 years through 25 years of age. As part of the accelerated approval process, Nova
1/26/15 - Novartis Receives FDA Approval for Cosentyx [Health & Beauty Close - Up]
Novartis reported the US Food and Drug Administration has approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. With the FDA approval of Cosentyx, a majority of people living with moderate-to-severe plaque psoriasis in the US now have available a new...
1/26/15 - Octapharma USA Announces FDA Approval for 2nd Octagam 10% Manufacturing Site, Expanding Product Availability
Octapharma USA today announced that the U.S. Food and Drug Administration has approved the company s manufacturing facility in Vienna, Austria for the production of Octagam 10%, which became available in the U.S. during October 2014. Octapharma USA today announced that the U.S. Food and Drug Administration has approved the company's manufacturin
1/26/15 - Symplmed Announces FDA Approval of Prestalia for Treatment of Hypertension
CINCINNATI& BEND, Ore. Symplmed Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Prestalia tablets, licensed from Servier, for the treatment of hypertension. This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline t
1/26/15 - Teva Receives FDA Approval for First Generic NexiumDelayed-Release Capsulesin the United States
Teva Pharmaceutical Industries Ltd. announces the Food and Drug Administration approval of the first generic equivalent to Nexium Delayed-Release Capsules in the United States. Teva is preparing to launch the product in the near future. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more
1/26/15 - TOS: FDA Approves First Medical Device for Obesity Treatment Targeting Brain-to-Stomach Signaling
"This is a novel device that interrupts signals from the stomach to the brain that are believed to be involved with stomach emptying and feelings of fullness," said Martin Binks, PhD, FTOS, Secretary/Treasurer of The Obesity Society and Associate Professor of Nutritional Sciences at Texas Tech University. "In clinical trials the device resulted in
1/26/15 - U.S. FDA Approves Rockwell's Triferic(TM) for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients
Rockwell Medical, Inc., a fully-integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food& Drug Administration has approved its drug Triferic for...
1/25/15 - Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US
NOVARTIS FINANCE S.A./ Novartis Bexsero vaccine approved by FDA for the prevention of meningitis B, the leading cause of bacterial meningitis in the US. Basel, January 23, 2015- Novartis announced today that the US Food and Drug Administration has granted accelerated approval of Bexsero for active immunization to prevent invasive meningococcal d
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