Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers December 5, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 5, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 37     Next >>     Go To Page:

12/5/16 - Alembic Pharma gets US FDA nod for anti-migraine drug [Cyprus Mail]
Alembic Pharmaceuticals has received approval from the US health regulator for Zolmitriptan orally disintegrating tablets, used for the treatment of migraine, in the American market. The company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Zolmitriptan Orally Disintegrating Tablets, 2.5
12/5/16 - DARZALEX daratumumab Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who...
DARZALEX daratumumab Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy. The approval comes three months after a supplemental Biologics License Application (sBLA) was submitted to the FDA in HYPERLINK "...
12/5/16 - FDA Approves Jardiance Tablets To Reduce Cardiovascular Death Risk In Diabetes
INDIANAPOLIS- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co. said that the U.S. Food and Drug Administration has approved a new indication for Jardiance or empagliflozin tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Jardiance is marketed by Boehringer...
12/5/16 - FDA approves Veltassa following updated label warning regarding drug-drug interactions
The updated US label for Veltassa recommends patients take Veltassa at least 3 hours before or 3 hours after other oral medications...
12/5/16 - Lipogems Announces New FDA Clearance
Lipogems' new FDA clearance better defines the indications as harvesting, concentrating and transferring of autologous adipose tissue, and expands the initial indications into the field of arthroscopy. In addition, the updated FDA clearance defines that the Lipogems System preserves the cell and tissue micro-architecture of the adipose tissue,...
12/5/16 - Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 insulin degludec and liraglutide injection
By a News Reporter-Staff News Editor at Diabetes Week- Novo Nordisk, a world leader in diabetes care, announced that the U.S. Food and Drug Administration approved the New Drug Application for Xultophy 100/ 3.6. "Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/ 3.6, that may make a difference in the
12/5/16 - Sanofi Receives FDA Approval of Soliqua 100/33 for the Treatment of Adults with Type 2 Diabetes
By a News Reporter-Staff News Editor at Diabetes Week Newswire/ HYPERLINK " http://www.sanofi.com/"\ nSanofi announced that the U.S. Food and Drug Administration approved once-daily Soliqua? 100/ 33 100 Units/mL& 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin or lixisenatide*. "Sanofi cont
12/5/16 - Sientra Receives FDA Approval of New Silicone Breast Implant Styles and Sizes
Sientra, Inc., a medical aesthetics company, today announced that it has received U.S. Food and Drug Administration pre-market supplement approval for four new breast implant styles in both shaped and round as well as additional profile and sizing options for nine existing implant offerings.. Jeffrey M. Nugent, Chairman and Chief Executive Office
12/5/16 - U.S. FDA approves Jardiance (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 5, 2016/ PRNewswire/ The U.S. Food and Drug Administration approved a new indication for Jardiance tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. JARDIANCE is marketed by Boehringer Ingelheim and Eli Lilly and Company. "As the o
12/4/16 - House approves expanded budgets for health agencies
BIOMEDICAL RESEARCH, FDA DRUG APPROVAL: Voting 392 for and 26 against, the House on Nov. 30 passed a bipartisan bill that would expand the National Institutes of Health budget for biomedical research; speed Food and Drug Administration procedures for bringing new drugs and devices to the market; expand Medicare and Medicaid coverage of mental-healt
12/2/16 - Merck & Co., Inc (NYSE:MRK) Gets Coveted Approval For Keytruda
Individual lung cancer patients may soonbe able to benefit from Keytruda, an immunotherapy drug from Merck & Co., Inc. (NYSE:MRK). The news comes after the confirmation by the New Jersey drug maker that it had gained a second priority review tag from the US Food and Drug Administration (FDA). Britain's healthcare cost-effectiveness watchdog NIC
12/2/16 - Orthogonal Congratulates Nanowear on the FDA Clearance of their Flagship Product, SimplECG. [Emirates News Agency (WAM) (United Arab Emirates)]
-Orthogonal, a Chicago- based medical device software company, is pleased to congratulate long-term client Nanowear on their recent FDA Class II 510 clearance for their flagship medical device, SimplECG. With this FDA approval, Nanowear has cleared a significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based...
12/1/16 - Cardiac Dimensions Announces Investigational Device Exemption Approval from FDA to Conduct U.S. Pivotal Study of the CARILLON Mitral Contour System for Functional Mitral Regurgitation
The multi-center, blinded, randomized controlled trial is designed to evaluate the CARILLON Mitral Contour System versus guideline directed medical management for the treatment of symptomatic FMR associated with heart failure, a condition affecting an estimated 2 million people in the U.S. 1,2. The CARILLON trial is designed to enroll 400 pat
12/1/16 - FDA approves final trials for MDMA to treat PTSD before legalization review
The US Food and Drug Administration has given the green light to phase three trials of MDMA to treat post-traumatic stress disorder, the final phase of validation required to turn the party drug into a legal medicine. Early trials of the drug, currently listed as a schedule 1 substance by the Drug Enforcement Administration along with heroin and co
12/1/16 - Helsinn Integrative Care Announces 510(K) FDA Clearance for Medical Device Xonrid Gel
Helsinn Integrative Care, Helsinn's business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, today announces that Xonrid Gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical device in the EU, has received 510 FDA clearance in the US. Riccardo Braglia, Helsinn Group Vice Chair
12/1/16 - Orthogonal Congratulates Nanowear on the FDA Clearance of their Flagship Product, SimplECG?.
Orthogonal, a Chicago- based medical device software company, is pleased to congratulate long-term client Nanowear on their recent FDA Class II 510 clearance for their flagship medical device, SimplECG. With this FDA approval, Nanowear has cleared a significant hurdle in commercializing remote cardiac monitoring devices that rely on cloth-based...
11/30/16 - FDA Grants Diazyme 510(k) Clearance to Market Its Direct HbA1c (Enzymatic, On-Board Lysis) Assay for Clinical Chemistry Analyzers
Diazyme Laboratories today announced that the U.S. Food and Drug Administration has granted 510 clearance to market its Direct HbA1c assay. HbA1c refers to glycated hemoglobin which occurs when hemoglobin, a protein within red blood cells that transports oxygen through the body, joins with glucose in the blood, thereby becoming glycated.
11/30/16 - Global First IND for Subcutaneous Injectable anti-PD-L1 Domain Antibody Receives FDA Approval
SUZHOU, China& CHENGDU, China 3 D Medicines Co., Ltd. and Suzhou Alphamab Co., Ltd. announced today that the U.S. FDA has completed its review of the IND for their drug KN035 and informed the pharmaceutical company of their approval. Ting Xu, Chairman and CEO of Alphamab. We are thrilled by the milestone achievement. John Gong, CEO of 3 D Me
11/30/16 - Lupin Gets FDA Approval For Generic Nuvigil Tablets
NEW DELHI- Lupin Limited announced that its US subsidiary Lupin Pharmaceuticals Inc. has received final approval for its Armodafinil Tablets 50 mg, 150 mg, 200 mg and 250 mg from the United States Food and Drug Administration to market a generic version of Cephalon, Inc.' s Nuvigil Tablets 50 mg, 150 mg, 200 mg and 250 mg. Lupin's Armodafinil Ta
11/30/16 - NATCO Receives Final Approval for Generic Armodafinil Tablets for US Market
Natco Pharma Limited announced final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (FDA) for generic version of Armodafinil Tablets, 50 mg, 150 mg, and 250 mg.
11/30/16 - SuperSonic Imagine Receives FDA 510(k) Clearance for Breast- and Liver-Imaging Modes [Arab News (Saudi Arabia)]
SuperSonic Imagine has received 510 clearance from the U.S Food and Drug Administration for its Aixplorer platform imaging modes, including improved ones for breast imaging. This clearance is the culmination of several years of research and development on our Aixplorer platform, Jacques Souquet, founder and chief innovation officer for SuperSonic..
11/30/16 - Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Lotion 0.05%
Teligent originally submitted this ANDA to the FDA in September 2015. "Teligent received FDA approval for Clobetasol Propionate Lotion 0.05% in just less than fifteen months from our original submission date in September 2015. Teligent now has two products which have been approved by the FDA in a first round review, which exceeds current industry
11/29/16 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2)...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505 Applications. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Abbreviated New Drug Applications and 505 Applications" has been approved by the Office of...
11/29/16 - ARIAD Announces FDA Full Approval and Label Update for Iclusig (ponatinib) Based on Long-Term Efficacy and Safety Data from Phase 2 PACE Clinical Trial
ARIAD Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has granted Iclusig full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor...
11/29/16 - ARIAD Pharma Announces FDA Full Approval And Label Update For Iclusig
WASHINGTON- ARIAD Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has granted Iclusig full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or CML or Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase...
Articles(s): 1 - 25 of 37     Next >>     Go To Page:


© 2016 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Men's Health in Older Adults: Benign Prostatic Hyperplasia and Erectile Dysfunction
This lesson is supported by:
RxSchool
Pharmacy Spanish
This lesson is supported by:
RxSchool
Drug Therapy Management Series Part III: Geriatric Disorders
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2009 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415