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 The leading web portal for pharmacy resources, news, education and careers November 23, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 23, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 103     Next >>     Go To Page:

11/23/17 - 2nd-generation HPV vaccine approved
A second-generation HPV vaccine has been approved by China Food and Drug Administration for clinical testing, the developer said yesterday. The research is led by the National Institute of Diagnostics and Vaccine Development in Infectious Diseases, based at Xiamen University in southeast China's Fujian Province. Developers at Xiamen University said
11/23/17 - FDA approves first-ever two-drug HIV regimen, GSK`s Juluca [Sport360]
GlaxoSmithKline has announced that the FDA has awarded US marketing authorisation to the first two-drug regimen in the treatment of HIV. Juluca, as the therapy is known, is a combination of dolutegravir an integrase inhibitor from GSKs majority-owned ViiV Healthcare and rilpivirine, a non-nucleoside reverse transcriptase inhibitor developed by John
11/23/17 - FDA Approves Mala 48
The Food and Drugs Authority has issued a certificate of registration for the herbal medicine Mala 48 manufactured by Diagnostic Herbal Clinic. Diagnostic Herbal Clinic has become a one-stop shop for people living with chronic diseases and would want to try something aside orthodox healthcare in the country. The certification of Mala 48, therefore,
11/23/17 - FDA approves remote programming feature for cochlear implants [Syrian Arab News Agency]
The programming feature is for patients who have had their cochlear implant for more than six months and are comfortable with the programming process. Speaking about the approval, Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDAs Center for Devices and Radiological Health, said:. The FDA approved
11/23/17 - FDA approves ViiV Healthcares two-drug regimen to treat HIV-1 infection [Sudan Tribune]
Specialist HIV firm ViiV Healthcare has secured approval from the US Food and Drug Administration for its two-drug regimen Juluca to treat certain adults with human immunodeficiency virus type 1. ViiV Healthcare CEO Deborah Waterhouse said: The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in H
11/23/17 - GSK gets boost as first two-drug regimen for HIV gets US approval [Arab Times (Kuwait)]
Medicines regulator the US Food and Drug Administration has given the green light to a once-daily pill combining two previously approved drugs: dolutegravir and rilpivirine. Juluca is produced by ViiV Healthcare, a HIV specialist business majority-owned by GSK. US and Japanese drug giants Pfizer and Shionogi also have stakes.
11/23/17 - Strides arm gets USFDA nod for altitude sickness tablets [Arab Times (Kuwait)]
Strides Shasun today said its wholly-owned subsidiary has received approval from the US health regulator for Acteazolamide tablets, used to prevent and reduce symptoms of altitude sickness. In a BSE filing, it said Strides Pharma Global Pte. has received approval from the United States Food and Drug Administration for Acteazolamide tablets USP, 125
11/23/17 - US FDA approves drug duo pill for HIV [All Iraq News Agency (AIN)]
The US Food and Drug Administration has approved ViiV Healthcares two-drug treatment for HIV-1 maintenance, the first time the drugs have been combined into a single pill. ViiV Healthcare, which is majority owned by GlaxoSmithKline, and has Pfizer and Shionogi Limited as shareholders, said the combination therapy aims to reduce drug intake.
11/22/17 - Cipla Receives Final Approval for Generic Dacogen
Mumbai, India- Cipla Ltd, a global pharmaceutical company, today announced that it has received final approval for its Abbreviated New Drug Application for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration to market generic version of Otsuka America Pharmaceutical Inc.' s Dacogen. About Cipla Ltd
11/22/17 - CORRECTION: RMS Medical Products Announces New FDA Clearance, Warning Letter Closed, and Organizational Changes
CHESTER, NY/ ACCESSWIRE/ November 22, 2017/ Repro Med Systems, Inc., dba RMS Medical Products, today announced FDA developments and organizational changes. The FDA has officially notified RMS that the Warning Letter issued on February 26, 2016 has been closed. Andy Sealfon, CEO of RMS, stated, "We are thrilled and excited that FDA has recognized th
11/22/17 - FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
SILVER SPRING, Md., Nov. 22, 2017/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not u
11/22/17 - FDA Approves RxSight's Light Adjustable Lens, First IOL To Enable Refractive Correction After Cataract Surgery
RxSight, Inc. announced today that the U.S. Food and Drug Administration has approved the RxSight? Light Adjustable Lens and the Light Delivery Device for patients with pre-existing astigmatism of? 0.75 diopters undergoing cataract surgery. This action ushers in a new era in the treatment of cataracts, as RxSight's Light Adjustable Lens is th
11/22/17 - Glenmark Pharmaceuticals receives ANDA approval for HAILEY 24 Fe 1 mg20 mcg
Glenmark's current portfolio consists of 128 products authorized for distribution in the U.S. marketplace and 59 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio
11/22/17 - Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 Infection
Janssen Therapeutics, Division of Janssen Products, LP, today announced that the U.S. Food and Drug Administration has approved JULUCA (R), the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection in certain adults living with the disease who are virologically suppressed. JULUCA (R) is a
11/22/17 - Juluca (Dolutegravir and Rilpivirine) Approved in US as First 2-Drug Regimen, Once-Daily, Single Pill - a Complete Regimen for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
Deborah Waterhouse, CEO ViiV Healthcare said, "The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-12 an
11/22/17 - Juluca (Dolutegravir and Rilpivirine) Approved in US as First 2-drug Regimen, Once-daily, Single Pill - a Complete Regimen for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
Deborah Waterhouse, CEO ViiV Healthcare said, "The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-1 and
11/22/17 - Juluca (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration has approved Juluca , indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed o
11/22/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
DUBLIN- Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. commercial launch for its portfolio of Azure pacemakers with BlueSynctechnology. Azure pacemakers feature Medtronic- exclusive BlueSync technology, which enables automatic, secure wireless remote monitoring via the Medtronic CareLinkNetwork, providing timely..
11/22/17 - RMS Medical Products Announces New FDA Clearance, Warning Letter Cosed, and Organizational Changes
CHESTER, NY/ ACCESSWIRE/ November 22, 2017/ Repro Med Systems, Inc., dba RMS Medical Products, today announced FDA developments and organizational changes. The FDA has officially notified RMS that the Warning Letter issued on February 26, 2016 has been closed. Andy Sealfon, CEO of RMS, stated, "We are thrilled and excited that FDA has recognized th
11/22/17 - Senate Approves Greg Walden Bill to Ensure Military Access to Lifesaving Medical Treatments
Greg Walden, R- Oregon, issued the following news release:. Greg Walden to address a provision in the National Defense Authorization Act that would have undermined the authority of the U.S. Food and Drug Administration. "H.R. 4374 will establish important new authorities for the Food and Drug Administration and the Department of Defense to ensure
11/22/17 - Teligent, Inc. Announces FDA Approval of Erythromycin Topical Solution USP, 2% [Syrian Arab News Agency]
-Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Companys abbreviated new drug application from the U.S. Food and Drug Administration of Erythromycin Topical Solution USP, 2%. Teligent now has twenty-three topical generic pharmaceutical products in the US portfolio, in ad
11/22/17 - Teligent, Inc. Announces First FDA Generic Approval of Hydrocortisone Butyrate Lotion 0.1%
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 Hydrocortisone Butyrate Lotion 0.1%. As we were the first ANDA applicant to submit an ANDA with a paragraph IV certification for H
11/22/17 - ViiV Healthcare : FDA Okays First Two-drug Regimen For Certain Patients With HIV
LONDON- ViiV Healthcare, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, said that the US Food and Drug Administration has approved Juluca, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed on a stable antiretroviral or ART regimen fo
11/21/17 - Biocon shares rise 7% after Bengaluru unit gets US FDA clearance [Arab Times (Kuwait)]
Biocon Ltds shares jumped over 7% after the company said on Monday that its manufacturing facility in Bengaluru, which had received observations relating to lapses in quality compliance earlier this year, has been cleared by the US Food and Drug Administration. The US FDA has issued an Establishment Inspection Report in relation to the cGMP inspect
11/21/17 - Chugai's HEMLIBRA Receives the World's First Regulatory Approval from FDA for Hemophilia A with Inhibitors
The US Biologics License Application was submitted by Genentech, a member of Roche Group. 'We are pleased that HEMLIBRA, a biopharmaceutical created by Chugai scientists based on their exceptional idea, has received its first regulatory approval,' said Chugai's President& COO, Tatsuro Kosaka.' HEMLIBRA is a first in class biopharmaceutical which is
Articles(s): 1 - 25 of 103     Next >>     Go To Page:


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