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 The leading web portal for pharmacy resources, news, education and careers March 23, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 23, 2019

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 250     Next >>     Go To Page:

12/31/17 - NAB approves corruption probe against NWA Agency Surgeon, FDA, FATA Secretariat officers
PESHAWAR: The National Accountability Bureau has approved inquiry against Agency Surgeon of North Waziristan, FATA Secretariat and FATA Development Authority officers over corruption and misuse of powers. The Executive Board of the NAB Khyber Pakhtunkhwa met in Peshawar on Thursday with the director general in the chair. Inquiry was also approved..
12/30/17 - La Jolla Pharma Gets FDA Approval for Blood Pressure Drug [Sudan Tribune]
Last week, La Jolla Pharmaceutical Company received FDA approval for their low blood pressure injectible Giapreza. The intravenous injectible is used to raise blood pressure in adults with certain symptoms like sepsis, shock, and hypertension, but can also cause dangerous blood clots. In a 321 patient clinical trial Giapreza raised blood pressure a
12/30/17 - New addiction treatment "Sublocade" approved by FDA
Approved by the FDA in November 2017, the new treatment option can be best described as a combination between Vivitrol and Suboxone. I'm all for giving people choices, " Hocking County Municipal Court Judge Fred Moses said. However, Indivior Inc., which produces Sublocade, has stated that it will offer a co-pay assistance program as well as a Subox
12/29/17 - Boston Scientific Receives U.S. FDA Approval for the Vercise Deep Brain Stimulation System
By a News Reporter-Staff News Editor at Health& Medicine Week Boston Scientific Corporation announced that it has received approval from the U.S. Food and Drug Administration for the Vercise? Deep Brain Stimulation System. The approval was based on the INTREPID study, the first multi-center, prospective, double-blind, randomized sham-controlled
12/29/17 - Chemence Medical Receives FDA Clearance for Exofin Fusion Skin Closure System
By a News Reporter-Staff News Editor at Drug Week Chemence Medical, Inc., a manufacturer and distributor of adhesive-based medical devices, announced it received Food and Drug Administration clearance to market and sell Exofin Fusion , a new skin closure system for medium to large wounds. Exofin Fusion combines a self-adhering flexible mesh str
12/29/17 - Glenmark receives ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets 1 mg 20 mcg
Glenmark's current portfolio consists of 130 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
12/29/17 - Ignyta Reports FDA Clearance of IND for RXDX-106, a Novel Immunomodulatory Agent and TYRO3, AXL, MER (TAM) Inhibitor
Ignyta, Inc., a biotechnology company focused on precision medicine in oncology, today announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for RXDX-106, a novel oral immunomodulatory agent and TAM inhibitor, in patients with solid tumors. In preclinical studies, RXDX-106 has demonstrated the pot
12/29/17 - Lupin gets USFDA nod for generic psoriasis treatment solution [Arab Times (Kuwait)]
Pharma major Lupin Ltd today said it has received final approval from the US health regulator for its generic version of Dovonex scalp solution used in treatment of psoriasis of scalp. The approval by the US Food and Drug Administration to Lupin`s calcipotriene topical solution is for strength of 0.005 per cent, the company said in a statement.
12/29/17 - Lupin receives USFDA nod for Calcipotriene Topical Solution, generic of Dovonex Scalp solution [India Infoline News Service]
Lupin, through its filing on BSE, has informed that it has received final approval for its Calcipotriene Topical Solution, 0.005% from the United States Food and Drug Administration to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.. Lupin s Calcipotriene Topical Solution, 0.005% is the AT rated gen
12/29/17 - Mylan Adds to U.S. Women's Healthcare Portfolio With FDA Approval of First Generic for Estrace Cream
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2017/ PRNewswire/ Global pharmaceutical leader Mylan N.V. today announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application
12/28/17 - Bausch + Lomb Receives FDA Approval of LUMIFY - The Only Over-The-Counter Eye Drop with Low-Dose Brimonidine for the Treatment of Eye Redness
LAVAL, Quebec- Bausch+ Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., today announced that the U.S. Food and Drug Administration has approved LUMIFY as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness.
12/28/17 - FDA approves drug to treat dangerously low blood pressure
'Shock, the inability to maintain blood flow to vital tissues, can result in organ failure and death,' said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.' There is a need for treatment options for critically ill hypotensive patients who do not ade
12/28/17 - FDA approves Nanobiotix`s first Immuno-Oncology trial [Sport360]
NANOBIOTIX, a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced the U.S. Food and Drug Administration has approved its Investigational New Drug Application for NBTXR3, a first-in-class nanoparticle designed for direct injection into cancerous tumors, activated by stereotactic ablative...
12/28/17 - FDA approves Roche's Perjeta for adjuvant treatment of specific type of early breast cancer
Roche today announced the US Food and Drug Administration has approved Perjeta, in combination with Herceptin and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.1 People should receive the adjuvant Perjeta-based regimen for one year. The FDA has also converted the previously granted accelerated.
12/28/17 - FDA clears stereotactic radiotherapy system for use in treating breast cancer
Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. 'With today's clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue,
12/28/17 - Genentech - FDA Approves Genentech's Perjeta for Adjuvant Treatment of Specific Type of Early Breast Cancer
South San Francisco, CA- Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration has approved Perjeta, in combination with Herceptin and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. The FDA has also converted the previously granted accelerated approval of
12/28/17 - Horizon Pharma plc Announces FDA Approval to Expand the Indication for PROCYSBI (cysteamine bitartrate) Delayed-Release Capsules to Include Children One Year of Age and Older Living with Nephropathic Cystinosis [Sudan Tribune]
Horizon Pharma plc today announced the U.S. Food and Drug Administration has approved an expansion to the indication for PROCYSBI delayed-release capsules to include children one year of age and older living with nephropathic cystinosis. PROCYSBI was previously FDA- approved for adults and children as young as two years of age. Data included in the
12/28/17 - House okays promotion of safe, non-hazardous children's products [Philippines News Agency]
The House of Representatives has approved on third and final reading a measure that seeks to regulate the importation, manufacture, distribution, and sale of children's products containing hazardous chemicals. Under the bill, the Food and Drug Administration shall prepare a list of hazardous chemicals which are to be banned or prohibited from being
12/28/17 - La Jolla Pharmaceutical Company Announces FDA Approval of Giapreza
SAN DIEGO- La Jolla Pharmaceutical Company today announced that the U.S. Food and Drug Administration has approved GiaprezaTM to increase blood pressure in adults with septic or other distributive shock. 'We appreciate FDA's rapid review and approval of Giapreza and are especially grateful to the patients, families and dedicated critical care teams
12/28/17 - Lupin receives final approval from USFDA for Calcipotriene Topical Solution [India Infoline News Service]
Lupin, through its filing on BSE, has informed that it has received final approval for its Calcipotriene Topical Solution, 0.005% from the United States Food and Drug Administration to market a generic version of Dovonex Scalp Solution, 0.005% of Leo Pharmaceutical Products Ltd.. The Company is a significant player in the Cardiovascular, Diabetolog
12/28/17 - MERCK - FDA APPROVES SGLT2 INHIBITOR STEGLATRO AND FIXED-DOSE COMBINATION STEGLUJAN FOR ADULTS WITH TYPE 2 DIABETES
KENILWORTH, N.J.& NEW YORK- Merck, known as MSD outside the United States and Canada, and Pfizer Inc., today announced that the U.S. Food and Drug Administration has approved STEGLATROTM tablets, an oral sodium-glucose cotransporter 2 inhibitor, and the fixed-dose combination STEGLUJAN tablets. STEGLATRO is indicated as an adjunct to diet and exerc
12/28/17 - New glaucoma drug from a Duke University spinoff has an edge over other treatments [The News & Observer (Raleigh, N.C.)]
Dec. 28 A 12- year-old Duke University spinoff founded by two Duke professors has received regulatory approval for its first drug: once-a-day eye drops for glaucoma patients. Aerie Pharmaceuticals received approval for the medication, Rhopressa, from the Food and Drug Administration on Dec. 18. The company called the FDA approval "a testament to
12/28/17 - Novartis announces FDA approval of its first and only CML therapy with TFR data in product label [Algeria Press Service]
Tasigna is now the first and only BCR-ABL tyrosine kinase inhibitor to include data about attempting treatment discontinuation in eligible adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale[ IS].
12/28/17 - Novartis drug Tasigna is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label
Basel- Novartis announced today that the US Food and Drug Administration approved the inclusion of Treatment-free Remission data in the Tasigna US product label.
12/28/17 - Researchers Submit Patent Application, "Accommodative Intraocular Lens", for Approval (USPTO 20170348094)
By a News Reporter-Staff News Editor at Politics& Government Week From Washington, D.C., VerticalNews journalists report that a patent application by the inventors SOHN, Zev; GROSS, Yossi, filed on June 1, 2016, was made available online on December 14, 2017. The patent's assignee is Rainbow Medical Ltd.. The Crystalens.RTM. is an AIOL that has r
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