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 The leading web portal for pharmacy resources, news, education and careers November 24, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 24, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 89     Next >>     Go To Page:

11/24/17 - FDA approves first implanted lens that can be adjusted after cataract surgery [Tehran Times (Iran)]
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 using glasses. Cataracts are a common eye condition where the
11/24/17 - FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
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 using glasses. Cataracts are a common eye condition where the
11/24/17 - FDA approves first two-drug regimen for certain patients with HIV
The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 instead of three or more drugs included in standard HIV treatment. 'Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patien
11/24/17 - FDA approves medical system to adjust artificial lens after cataract surgery. [Sudan Tribune]
The lens and device are the first medical device system approved by the FDA to make small adjustments to the artificial lens after cataract surgery. The FDA approved the device after it passed the safety and efficacy clinical test on 600 patients. Until now, refractive errors that are common following cataract surgery could only be corrected with g
11/24/17 - Glenmark Pharmaceuticals receives ANDA approval for HAILEY TM Fe 1 20
Glenmark's current portfolio consists of 129 products authorized for distribution in the U.S. marketplace and 58 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
11/24/17 - Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA, for the Treatment of HIV-1 Infection
TITUSVILLE, N.J- Janssen Therapeutics, Division of Janssen Products, LP, today announced that the U.S. Food and Drug Administration has approved JULUCA, 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.
11/24/17 - ViiV Healthcare`s two-drug regimen, Juluca receives US FDA approval for certain patients with HIV [Syrian Arab News Agency]
ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, 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 on a stable.
11/24/17 - Zydus Cadila gets USFDA nod to sell erectile dysfunction drug [All Iraq News Agency (AIN)]
Drug firm Zydus Cadila today said it has received approval for the US health regulator to market Tadalafil tablets, used for the treatment of erectile dysfunction, in the American market. The company has received tentative approval from the US Food and Drug Administration to market Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg, and
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 - GSK group of companies - Juluca approved in US as first 2-drug regimen, once-daily, single pill
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 on a s
11/23/17 - 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..
11/23/17 - 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 - Teligent, Inc. Announces First FDA Generic Approval of Hydrocortisone Butyrate Lotion 0.1% [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 Hydrocortisone Butyrate Lotion 0.1%. As we were the first ANDA applicant to submit an ANDA with a paragraph IV certification for Hydroc
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.
11/23/17 - ViiV Healthcare announces US FDA approval for Juluca
London- 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 suppresse
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
Articles(s): 1 - 25 of 89     Next >>     Go To Page:


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