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 The leading web portal for pharmacy resources, news, education and careers March 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 26, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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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.
2/24/17 - bioMrieux's VIDASB?R?A?H?M?SPCT? Becomes the First FDA-Cleared Procalcitonin Assay as an Aid for Antibiotic Stewardship in Respiratory Infections and Sepsis
With these two new additional claims, VIDAS B? R? A? H? M? S PCT? becomes the first and only FDA- cleared procalcitonin test available in the U.S. market to assist physicians in antibiotic management for patients with suspected or confirmed LRTI or sepsis. Antimicrobial resistance is considered as a major threat to public health and
2/24/17 - FDA Clears Test To Help Manage Antibiotic Treatment For Respiratory Infections
WASHINGTON- The U.S. Food and Drug Administration Thursday cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis.
2/24/17 - Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage XR
Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug.
2/24/17 - Intersect ENT Announces FDA Approval of Newest Steroid Releasing Implant, PROPEL Contour, for Use in Treating the Frontal and Maxillary Sinuses
Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the company has received approval from the U.S. Food and Drug Administration for its PROPEL Contour steroid releasing sinus implant. Intersect ENT's PROPEL Contour steroid releasing sinus implant. The approv
2/24/17 - INTERSECT ENT, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01 Regulation FD Disclosure. On February 24, 2017, Intersect ENT, Inc. issued a press release announcing that the Company has received approval from the U.S. Food and Drug Administration for its PROPEL Contour steroid releasing sinus implant. Description 99.1 Press release entitled "Intersect ENT Announces FDA Approval of Newest Steroid R
2/24/17 - NetworkNewsBreaks Intellipharmaceutics International, Inc. (NASDAQ: IPCI) Shares Higher on FDA Approval of Two Strengths of Generic Glucophage XR
Intellipharmaceutics International shares were up 27% this morning following news that it has received final approval for its abbreviated new drug application for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths from the U.S. Food and Drug Administration. We are actively evaluating options to realize commercial...
2/23/17 - Finch Therapeutics Announces Strategic Collaboration with OpenBiome to Develop Microbiome Therapies for FDA Approval
Finch Therapeutics, Inc., a microbiome therapeutics company, and OpenBiome, a leading public stool bank, today announced a collaboration to develop FIN-403, an orally administered microbial therapy for approval by U.S. Food and Drug Administration in recurrent C. difficile infections. OpenBiome has transformed the standard of care for C. diffici
2/23/17 - IDC Receives FDA Approval for Innovative DR Imaging Devices
Calgary, Alberta- Imaging Dynamics Company Ltd. is pleased to announce that it received notification today that the United States Food and Drug Administration has granted Market Clearance approval for its new Digital Radiography product line- Aquarius 8600 1717 TC and Aquarius 8600 1417 TC. These products utilize and integrate into IDC s proprie
2/23/17 - Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz New Animal Drug Application
By a News Reporter-Staff News Editor at Politics& Government Week- Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, announced it has received a technical section complete letter for effectiveness from the U.S. Richard Chin, CEO of KindredBio, stated, "This is a major milestone for KindredBi
2/23/17 - Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC
Novartis today announced that the US Food and Drug Administration accepted the Company's supplemental New Drug Application for filing, and granted Priority Review for the expanded use of Zykadia as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase- positive as detected by
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