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 The leading web portal for pharmacy resources, news, education and careers February 25, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 25, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 250     Next >>     Go To Page:

12/31/16 - LUPIN GETS USFDA NOD FOR PITAVASTATIN TABLETS
Pharmaceutical company Lupin has received tentative approval from the United States Food and Drug Administration to market its cholesterol lowering Pitavastatin tablets in the American market. has received approval for Pitavastatin tablets in the strength of 1 milligram, 2 mg and 4 mg. Pitavastatin is a generic version of Kowa's Livalo tablets in t
12/30/16 - Aurobindo Pharma gets US FDA approval for 2 drugs, stocks up 3% [India Infoline News Service]
Aurobindo Pharma has received US Food and Drug Administration's approval for two of its generic drugs, following which the company stocks gained positive traction. Aurobindo Pharma has received US Food and Drug Administration's approval for two of its generic drugs, following which the company stocks gained positive traction. Aurobindo Pharma Ltd i
12/30/16 - Pharmaceuticals Newsletter - December 26 to 30, 2016 [India Infoline News Service]
This week, Lupin received tentative approval for generic Giazo Tablets, Aurobindo Pharma got US FDA approval for 2 drugs and Glenmark Pharma gets USFDA approval for Tretinoin Capsules. Lupin receives tentative approval for generic Giazo Tablets Pharma Major Lupin Limited announced that it has received tentative approval for its Balasalazide Disodiu
12/29/16 - Lupin receives tentative approval for generic Giazo Tablets [India Infoline News Service]
Lupin's Balasalazide Disodium tablets 1.1 gm are the AB rated generic equivalent of Salix Pharmaceuticals Inc's Giazo Tablets, 1.1 gm.Pharma Major Lupin Limited announced today that it has received tentative approval for its Balasalazide Disodium Tablets, 1.1 gm from the United States Food and Drug Administration to market a generic version of Sali
12/29/16 - New Florida laws governing opioids, cough syrup to take effect Jan. 1 [The Bradenton Herald]
Dec. 28 Floridians will see a few new changes in the New Year as three laws take effect starting Jan. 1. Minimum wage across Florida will also go up 5 cents to $8.10 starting Sunday. Abuse-deterrent labeling is put on a drug that has been approved by the U.S. Food and Drug Administration to claim that the drug is expected to deter prescription dr
12/28/16 - FDA approves first drug for spinal muscular atrophy
Release date- 23122016- The U.S. Food and Drug Administration today approved Spinraza, the first drug approved to treat children and adults with spinal muscular atrophy, a rare and often fatal genetic disease affecting muscle strength and movement. 'There has been a long-standing need for a treatment for spinal muscular atrophy, the most common gen
12/28/16 - GLENMARK GETS FDA NOD FOR LEUKAEMIA TREATMENT DRUG
Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for selling its generic version of tretinoin capsules 10 mg. The drug is used for the treatment of leukaemia. Tretinoin capsules are the generic version of Vesanoid Capsules 10 mg of Hoffmann La Roche Inc. The drug is no longer marketed in USA..
12/28/16 - Mylan Launches Generic Zovia Tablets
HERTFORDSHIRE, England and PITTSBURGH, Dec. 28, 2016/ PRNewswire/ Mylan N.V., today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/ 0.05 mg. Mylan's subsidiary, Jai Pharma Limited, received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product
12/28/16 - Shire announces FDA approval of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] for use in Children and Surgical settings
Release date- 27122016- Lexington, Mass.- Shire plc announced today that the U.S. Food and Drug Administration has approved ADYNOVATE, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved ADYNOVATE for use in surgical settings for both adult and pedi
12/28/16 - Statlife Obtains FDA Clearance for Breast Density Software
Statlife has received U.S. FDA 510(k) clearance for DenSeeMammo, a software solution for breast density category assessment. DenSeeMammo provides a standardized and automatic breast density evaluation that mimics radiologists visual assessment according to the Breast Imaging Reporting and Data System 5th Edition guidelines.
12/27/16 - Expect Availability Of Biogen's Newly Approved Spinraza In Just One Week
The company, which got the FDA approval within three months of regulatory filing, said Spinraza will be made available for shipment in the United States to healthcare providers in approximately one week. This month, the U.S. Food and Drug Administration granted accelerated approval to Clovis Oncology Inc' s Rubraca to treat women with a certain typ
12/27/16 - Glenmark pharma receives US regulator`s approval for leukemia treatment drug [Palestine Chronicle, The]
Glenmark Pharmaceuticals has been granted a final approval from the US Food and Drug Administration for sale of Tretinoin Capsules, used in treatment of leukemia. According to IMS Health sales data for the 12 months to October 2016, Glenmark said the Vesanoid Capsules, 10 mg market achieved annual sales of approximately $22.0 million. At 11:52 a.m.
12/27/16 - Nephros Receives FDA 510(k) Clearance of HydraGuard(TM) 10" UltraFilter
Nephros, Inc., a commercial stage medical device company that develops and sells high performance liquid purification ultrafilters and an on-line mid-dilution hemodiafiltration system for use with a hemodialysis machine for the treatment of patients with end stage renal disease, announced that it has received 510 clearance from the U.S. Food and Dr
12/27/16 - Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), Pegylated] for use in Children and Surgical Settings
New FDA- approved i ndications for ADYNOVATE provides more h emophilia A patients access to proven proph y laxis with a simple, twice-weekly dosing schedule. Shire plc announced today that the U.S. Food and Drug Administration has approved ADYNOVATE, an extended circulating half-life recombinant Factor VIII treatment for hemophilia A, in pediatric
12/27/16 - Spinraza Wins 'Best Case Approval'; Leerink Raises Targets On Biogen, Ionis
The FDA has approved Spinraza for the treatment of all types of spinal muscular atrophy. Porges maintains an Outperform rating on Biogen Inc, while raising the price target from $355 to $368. In a separate note, Leerink's Paul Matteis reiterated a Market Perform rating on Ionis Pharmaceuticals Inc, while raising the price target from $40 to $47.
12/26/16 - FDA Approves First Drug For Spinal Muscular Atrophy
WASHINGTON- The U.S. Food and Drug Administration has approved Spinraza, the first drug approved to treat children and adults with spinal muscular atrophy. SMA is a rare and often fatal genetic disease affecting muscle strength and movement. "There has been a long-standing need for a treatment for spinal muscular atrophy, the most common genetic c
12/26/16 - FDA Clears Integration Between LifeScan's OneTouch Verio Flex Blood Glucose Monitoring System and WellDoc's BlueStar Diabetes Management Platform
By a News Reporter-Staff News Editor at Diabetes Week- HYPERLINK " http://www.onetouch.com/"\ nLifeScan, Inc., part of the Johnson& Johnson Diabetes Care Companies and a world leader in blood glucose monitoring, announced the U.S. Food and Drug Administration has cleared the wireless integration of the OneTouch Verio Flex blood glucose monitor
12/26/16 - Galderma Announces FDA Approval of Restylane Refyne and Restylane Defyne Dermal Fillers for Treatment of "Laugh Lines"
By a News Reporter-Staff News Editor at Clinical Trials Week- Galderma, a global leader focused on medical solutions in skin health, announced it has received U.S. Food and Drug Administration approval of two new products for the treatment of nasolabial folds or "laugh lines," in patients over the age of 21.1, 2 Restylane Refyne was approved f
12/26/16 - Lumendi Receives FDA Clearance to Market DiLumen? for Endolumenal Therapy
By a News Reporter-Staff News Editor at Pharma Business Week Connecticut- based medical device innovator Lumendi, LLC http://www.lumendi.com has announced it has received United States Food and Drug Administration 510 clearance for the DiLumen?, an endoscopic accessory that is indicated to ensure complete positioning of an endoscope in the larg
12/26/16 - Lupin gets tentative approval for generic Benicar tablets; stocks up 1% [India Infoline News Service]
Lupin's Olmesartan Medoximil tablets 5 mg, 20 mg and 40 mg are the AB rated generic equivalents of Daiichi Sankyo Inc's Benicar tablets, 5 mg, 20 mg and 40 mg. Pharma major Lupin Limited announced today that it has received tentative approval for its Olmesartan Medoximil tablets, 5 mg, 20 mg and 40 mg from the United States Food and Drug Administra
12/26/16 - Pfizer Receives FDA Approval for EUCRISATM crisaborole, a Novel Non-Steroidal Topical Ointment for Mild to Moderate Atopic Dermatitis Eczema
By a News Reporter-Staff News Editor at Clinical Trials Week Pfizer Inc. announced that the U.S. Food and Drug Administration approved EUCRISATM ointment 2%, a novel non-steroidal topical phosphodieterase-4 inhibitor for the treatment of mild to moderate atopic dermatitis in patients two years of age and older.1 AD, often called eczema, is a chro
12/26/16 - St. Jude Medical Announces FDA Clearance of EnSite Precision Cardiac Mapping System
By a News Reporter-Staff News Editor at Pharma Business Week St. Jude Medical, Inc., a global medical device company, announced FDA clearance of its EnSite Precision? cardiac mapping system and Advisor? FL Circular Mapping Catheter, Sensor Enabled?. The new EnSite Precision cardiac mapping system is the latest addition to the company's elec
12/26/16 - U.S. FDA approves Synjardy XR empagliflozin/metformin hydrochloride extended-release tablets for adults with type 2 diabetes
By a News Reporter-Staff News Editor at Diabetes Week The U.S. Food and Drug Administration has approved Synjardy XR tablets for adults with type 2 diabetes. SYNJARDY XR is the fourth FDA- approved treatment that contains empagliflozin. "Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage the
12/25/16 - The Year That Was: Novel Drug Approvals Of 2016
FOSTER CITY- Another busy and challenging year for the FDA is coming to a close. According to the Office of New Drugs Director John Jenkins, the sharp drop-off in the number of new molecular entities approved in 2016 is due to the following reasons:. -The number of Complete response Letters issued by the FDA in 2016 is more compared to last year.
12/24/16 - AirXpanders receives FDA de novo clearance for AeroForm Tissue Expander System [Seven Days (United Arab Emirates)]
With FDA clearance, the device can now be sold in the U.S., the worlds largest medical device market. As U.S. mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the U.S., said Mr Dodson. While approximately 70 percen
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