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 The leading web portal for pharmacy resources, news, education and careers August 22, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 22, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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8/22/17 - Aurobindo Pharma gets USFDA nod for anti-HIV drug [Arab News (Saudi Arabia)]
Aurobindo Pharma has received tentative approval from the USFDA for dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, used for the treatment of HIV, in the US market. In a BSE filing, Aurobindo Pharma said it has received "tentative approval from the US Food and Drug Administration under the US President`s Emergency Plan For AIDS
8/22/17 - B. Braun Launches New Dialyzer
B. Braun Medical issued the following news release:. B. Braun Medical Inc. today announced that the U.S. Food and Drug Administration has cleared its hemodialyzer, Diacap (R) Pro. "The newly developed fibers in Diacap Pro are designed to improve dialysis dose," said Samuel Amory, Vice President at B. Braun Medical.
8/22/17 - BESPONSA (inotuzumab ozogamicin) Approved for Treatment of Adult Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia, Available for Order at Biologics, Inc.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, announced today it has been selected by Pfizer, Inc. to be a specialty pharmacy provider for BESPONSA , a promising new IV therapy for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Approved by the U.S. Food and Drug Adminis
8/22/17 - FDA Approves IRWD's Gout Drug, It's A Thumbs Up For ALXN In EU, CRME Crushed
TOKYO- Today's Daily Dose brings you news about European approval of Alexion' s Soliris for an additional indication; Alkermes' New Drug Application for a major depressive disorder drug; Astellas' MORPHO trial progress; Axovant's move to NASDAQ from the Big Board; Cardiome's disappointing update related to its antiarrhythmic drug and FDA approval o
8/22/17 - FDA evaluates prescription opioid medications approved for children
The FDA has heard from professional groups, including the American Academy of Paediatrics about the use of opioid cough suppressants for children...
8/22/17 - Ironwood Pharmaceuticals Announces FDA Approval of DUZALLO for the Treatment of Hyperuricemia in Patients with Uncontrolled Gout
Release date- 21082017- CAMBRIDGE, Mass.- Ironwood Pharmaceuticals, Inc. today announced DUZALLO was approved by the U.S. Food and Drug Administration as a once daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone.
8/22/17 - Malin Announces U.S. FDA Approval for New Hourglass? Peripheral Embolisation Plug
Malin Corporation plc., an Irish based and globally operating life sciences company, today announced that its EMBA device, known as the Hourglass? Peripheral Embolisation Plug, was granted U.S. FDA 510 clearance to commence marketing in the US. Malin Executive Vice President, Sean Murphy said: The FDA approval of the Hourglass? device is a m
8/22/17 - Octapharma USA Announces FDA Approval of NUWIQ New Product Strengths, Expanding Hemophilia A Patient Treatment Options
Octapharma USA today announced the U.S. Food and Drug Administration has approved new product strengths for NUWIQ , offering added convenience by potentially reducing the number of vials needed for Hemophilia A patients. Octapharma USA today announced the U.S. Food and Drug Administration has approved new product strengths for NUWIQ , including
8/22/17 - Perrigo Announces Final FDA Approval and Settlement for the Store Brand OTC Equivalent of Nexium 24HR Capsules
Release date- 21082017- DUBLIN- Perrigo Company plc today announced that it has received final approval from the U.S. Food& Drug Administration for the store brand OTC equivalent of Nexium 24 HR capsules. The company also announced that it has reached a settlement of patent litigation with AstraZeneca allowing for the store brand OTC equivalent of
8/22/17 - Pfizers Besponsa gets FDA approval for treatment of B-cell precursor ALL [Algeria Press Service]
Developed jointly by Pfizer and Celltech, now known as UCB, Besponsa is an antibody-drug conjugate made up of a monoclonal antibody targeting CD22, a cell-surface antigen expressed on cancer cells in almost all B-ALL patients linked to a cytotoxic agent. Pfizer oncology global president Liz Barrett said: The approval of Besponsa is an important ste
8/22/17 - Statement from FDA Commissioner Scott Gottlieb, M.D. - FDA is carefully evaluating prescription opioid medications approved to treat cough in children
Release date- 21082017- There's perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. At a roundtable earlier this year, the FDA heard from professional groups, including the American Academy of Pediatrics and the American Academy of Family Physicians, about the use of cough suppressants, and
8/22/17 - Study Findings on Clinical Oncology Are Outlined in Reports from University of Oklahoma Health Sciences Center (Rucaparib: the past, present, and...
Study Findings on Clinical Oncology Are Outlined in Reports from University of Oklahoma Health Sciences Center. Our news editors obtained a quote from the research from the University of Oklahoma Health Sciences Center, "Rucaparib has received the US Food and Drug Administration approval for patients with deleterious mutation- associated advanced..
8/22/17 - Teligent Receives Fourth FDA Approval on 2017
Teligent received approval from the US Food and Drug Administration for Clobetasol Propionate Cream USP, 0.05 percent, Emollient. Based on recent QuintilesIMS Health data from June 2017, the total addressable market for this product is approximately $12.0 million. Clobetasol Propionate Cream USP, 0.05%, Emollient is Teligent s fourth FDA appr
8/22/17 - Teligent, Inc. Announces FDA Approval of Clobetasol Propionate Cream USP, 0.05%, Emollient
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company s abbreviated new drug application from the U.S. Food and Drug Administration of Clobetasol Propionate Cream USP, 0.05%, Emollient. Clobetasol Propionate Cream USP, 0.05%, Emollient is Teligent s fourth FD
8/21/17 - Achieve Announces FDA Acceptance of the Investigational New Drug Application IND for Cytisine as a Smoking Cessation Treatment
By a News Reporter-Staff News Editor at Clinical Trials Week Achieve Life Sciences, Inc. announced that the U.S. Food and Drug Administration has accepted the Investigational New Drug application for cytisine, an established smoking cessation treatment that has been approved and marketed in Central and Eastern Europe for more than 15 years.
8/21/17 - AstraZeneca, Merck get FDA OK for ovarian cancer drug
AstraZeneca and Merck& Co., Inc. announced that the US Food and Drug Administration has granted approval for Lynparza for some types of ovarian cancer. Sean Bohen, executive vice president, Global Medicines Development and chief medical officer, AstraZeneca, said: "Physicians have almost three years of clinical experience withLynparzaon the market
8/21/17 - FDA Approves Medicines360's sNDA for LILETTA levonorgestrel-releasing intrauterine system 52 mg to Prevent Pregnancy for up to Four Years
By a News Reporter-Staff News Editor at Pharma Business Week Allergan plc, a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration approved Medicines360's Supplemental New Drug..
8/21/17 - In2Bones USA Announces FDA Clearance on Two Key Implant Systems
By a News Reporter-Staff News Editor at Pharma Business Week In2Bones Global, Inc. announced that its In2Bones USA, LLC subsidiary has received U.S. Food and Drug Administration clearance for its new Fracture and Correction System. The System will be marketed under the 5 MS? Fracture Repair System and the CoLag? Locking Compression Screw Syst
8/21/17 - Ironwood Pharmaceuticals Announces FDA Approval of DUZALLO (lesinurad and allopurinol) for the Treatment of Hyperuricemia in Patients with Uncontrolled Gout
Ironwood Pharmaceuticals, Inc. today announced DUZALLO was approved by the U.S. Food and Drug Administration as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. DUZALLO is the first drug that combines the c
8/21/17 - Jubilant Life Sciences receives USFDA approval for Drax Exametazime [India Infoline News Service]
Jubilant Life Sciences has announced that Jubilant Pharma, a material wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant Draximage Inc, Montreal, Canada, has received US Food and Drug Administration approval for Drax Exametazime, for its New Drug Application. Jubilant Life Sciences has announced that Jubi
8/21/17 - Mauna Kea Technologies Receives Specific U.S. FDA 510K Clearance for Use of Cellvizio During Robotic-Assisted Surgery
By a News Reporter-Staff News Editor at Pharma Business Week Mauna Kea Technologies inventor of Cellvizio , the multidisciplinary confocal laser endomicroscopy platform, announced that it has received United States Food and Drug Administration 510 clearance for its CelioFlex? UHD Confocal Miniprobes? for use with Cellvizio in robotic-assist
8/21/17 - Mylan Receives Tentative Approval for "TLD" Under PEPFAR
By a News Reporter-Staff News Editor at AIDS Weekly Mylan N.V., a leading global pharmaceutical company, announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 5
8/21/17 - Perrigo Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium 24HR Capsules
Perrigo Company plc today announced that it has received final approval from the U.S. Food& Drug Administration for the store brand OTC equivalent of Nexium 24 HR capsules. Perrigo Executive Vice President and President, Consumer Healthcare Americas Jeff Needham stated, "This final approval and upcoming launch demonstrates the tremendous capab
8/21/17 - Renovis Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems
By a News Reporter-Staff News Editor at Pharma Business Week Renovis Surgical Technologies, Inc. announced that it has received 510 clearance from the U.S. Food and Drug Administration to market posterior lumbar Tesera porous titanium interbody fusion systems. This is the fifth product group featuring the Tesera porous titanium structure for w
8/21/17 - Statement from FDA Commissioner Scott Gottlieb, M.D. - FDA is carefully evaluating prescription opioid medications approved to treat cough in children
There's perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. At a roundtable earlier this year, the FDA heard from professional groups, including the American Academy of Pediatrics and the American Academy of Family Physicians, about the use of cough suppressants, and in particular opioid co
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