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

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 250     Next >>     Go To Page:

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
12/31/15 - Rfa fibre for bipolar intraluminal application for varicose veins detail specification :us fda/european ce approved quality. inclusive of rental and... [TendersInfo (India)]
Tenders are invited for Rfa Fibre For Bipolar Intraluminal Application For Varicose Veins Detail Specification: Us Fda/ European Ce Approved Quality. Instructions/Remarks: All The Firms Participating In E-Tender Enquiry To Upload The Details Of The Offered Item In The Form Of Scanned Copy Of The Photo Of The Offered Item Showing All Relevant Detail
12/31/15 - TORRENT GETS US NOD FOR ARTHRITIS DRUG
Torrent Pharmaceutical Ltd has obtained the approval of the US Food and Drug Administration to launch a generic arthritis drug. The company will launch Celacoxib capsules in 50 mg, 100 mg, 200 mg and 400 mg strengths. The drug is the generic version of Celebrex capsules of Pfizer.
12/31/14 - FDA OKs MP Biomedicals for HTLV Confirmatory Assay [Professional Services Close - Up]
MP Biomedicals reported that it has received FDA approval on the MP Diagnostics HTLV Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination. MP Biomedicals said the approval signifies the first ever FDA approved HTLV confirmatory assay in the U.S. MP Biomedicals continues to be focused on immunoblot confirmatory diagno
12/31/14 - FDA Approves Bovie Ultimate Generator [Professional Services Close - Up]
Bovie Medical has received FDA 510 approval for the Bovie Ultimate generator. According to a release from Bovie Medical, the Bovie Ultimate is a high frequency electrosurgical generator that can be used for delivery of RF energy and/or helium gas plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures.
12/31/14 - FDA Approves Somatuline Depot (lanreotide) Injection [Professional Services Close - Up]
Ipsen Biopharmaceuticals reported that Somatuline Depot Injection 120 mg was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors in adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.
12/31/14 - FDA Grants Approval to Cerus to Intercept Blood System for Plasma [Professional Services Close - Up]
Cerus said that the U.S. Food and Drug Administration has approved the Intercept Blood System for plasma. In a release, Cerus reported that the Intercept plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection when treating patients requiring therapeutic plasma transfusion.
12/31/14 - FDA OKs WaterWear for MED-EL's Rondo [Professional Services Close - Up]
MED-EL USA received FDA approval for the WaterWear fully waterproof cover for the all-in-one Rondo Audio Processor. WaterWear will be available in early 2015. The announcement was made at the 14th Symposium on Cochlear Implants in Children in Nashville, Tenn.. Within seconds, this reusable accessory transforms the Rondo into a completely waterproof
12/31/14 - Hospira obtains FDA approval for analgesic Dyloject Injection [EMBIN (Emerging Markets Business Information News]
Hospira has obtained approval from the US Food and Drug Administration for its Dyloject Injection, a nonsteroidal anti-inflammatory drug analgesic. Hospira senior vice-president and chief scientific officer Sumant Ramachandra said: In today's healthcare environment, pain management and patient satisfaction are important to hospitals.
12/31/14 - LUPIN GETS US FDA APPROVAL FOR HIV DRUG
The pharmaceutical company Lupin Ltd has received provisional approval from the United States Food and Drug Administration to market its generic version of Prezista tablets indicated for the. The company can market its Darunavir Ethanolate tablets in multiple strengths in the US market for treatment of HIV-1 infections. The sales data for Sep 2014
12/31/13 - Huntsman Cancer Institute Discovery Translates into Clinical FDA-Cleared Breast Cancer Test at ARUP Laboratories
By a News Reporter-Staff News Editor at Cancer Weekly The PAM50 breast cancer signature developed at the University of Utah and Huntsman Cancer Institute received FDA approval and will launch at ARUP Laboratories in Salt Lake City. The discovery of PAM50 was a collaborative effort between a research group at Huntsman Cancer Institute led by Phili
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
12/30/15 - BTG Announces FDA Approval of VISTOGARD Uridine Triacetate as Antidote to Overdose and Early Onset, Severe, or Life-Threatening Toxicities from...
By a News Reporter-Staff News Editor at Biotech Week BTG plc announced that the United States Food and Drug Administration has approved Wellstat Therapeutics' VISTOGARD as the first and only drug to treat patients following an overdose of chemotherapy drugs 5- fluorouracil or capecitabine, or in patients exhibiting early-onset, severe or...
12/30/15 - Lupin surges after FDA nod for Fyavolv tablets [India Infoline News Service]
Shares of Lupin are currently trading 0.44% higher at Rs. 1,849.25 on BSE after the company yesterday received FDA approval for Fyavolv tablets. The scrip opened higher at Rs. 1,860 as against its previous close of Rs. 1,841.15. It hit a high and a low of Rs. 1,865 and Rs. 1,842 respectively. It is indicated for the treatment of moderate to severe
12/30/15 - USFDA nod! Aurobindo hits 52-week high [India Infoline News Service]
Shares of Aurobindo Pharma are currently trading 0.79% higher at Rs. 879 on BSE. The scrip today hit a fresh 52- week high of Rs. 884.90 buoyed by last week's FDA approval for Famotidine Tablets. On December 24, the company received final approval from the US Food& Drug Administration to manufacture and market Famotidine Tablets USP, 20 mg and 40 m
12/30/15 - Wellstat Announces FDA Approval of VISTOGARD Uridine Triacetate, the First Antidote to Treat Overdoses and Early-Onset Severe Toxicities Due to...
By a News Reporter-Staff News Editor at Biotech Week Wellstat Therapeutics Corporation announced that the US Food and Drug Administration has approved VISTOGARD as the first and only antidote for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy agents 5- Fluorouracil or capecitabine regardless of th
12/30/14 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Recall Regulations
SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Infant Formula Recall Regulations" has been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville
12/30/14 - EOS imaging Gets FDA Approval for hipEOS [Professional Services Close - Up]
EOS imaging reported that the U.S. Food and Drug Administration has approved hipEOS, a 3 D hip arthroplasty planning software based on EOS stereo-radiographic 2 D/3D imaging. Developed by OneFit medical, an EOS imaging group company, the software enables surgeons to perform, using EOS unique stereo- radiographic 2 D/3D low dose images, pre-surgical
12/30/14 - FDA OKs MP Biomedicals for HTLV Confirmatory Assay [Professional Services Close - Up]
MP Biomedicals reported that it has received FDA approval on the MP Diagnostics HTLV Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination. MP Biomedicals said the approval signifies the first ever FDA approved HTLV confirmatory assay in the U.S. MP Biomedicals continues to be focused on immunoblot confirmatory diagno
12/30/14 - FDA Approves INTERCEPT Blood System for Plasma
By a News Reporter-Staff News Editor at Life Science Weekly Cerus Corporation announced that the U.S. Food and Drug Administration has approved the INTERCEPT Blood System for plasma. "We believe this approval to be a pivotal step toward giving U.S. blood centers a proactive approach for protecting the plasma supply," said William' Obi' Greenman,
12/30/14 - FDA approves Roche Ebola test for emergency use [EMBIN (Emerging Markets Business Information News]
Roche Holding AG said U.S. health regulators have approved its Ebola test for emergency use in response to the world's worst outbreak of the disease in West Africa. The U.S. Food and Drug Administration has approved Roche's LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection, the Swiss drugma
12/30/14 - Hospira Obtains FDA Approval Of Proprietary Analgesic Dyloject Injection
WASHINGTON- Hospira Inc. said that it has received approval from the U.S. Food and Drug Administration or FDA for Dyloject Injection, a proprietary nonsteroidal anti-inflammatory drug or NSAID analgesic. Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in.
12/30/14 - Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject Injection
Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration for Dyloject? Injection, a proprietary nonsteroidal anti-inflammatory drug analgesic. As a result, various medical organizations are now recommending a mult
12/30/14 - Hospira Receives U.S. FDA Approval of Proprietary Analgesic Dyloject?(diclofenac sodium) Injection
Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration for Dyloject? Injection, a proprietary nonsteroidal anti-inflammatory drug analgesic. As a result, various medical organizations are now recommending a mu
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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