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 The leading web portal for pharmacy resources, news, education and careers December 15, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 15, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 64     Next >>     Go To Page:

12/15/17 - FDA approves Abilify trackable pill from Otsuka
US regulators have approved the first pill that can be digitally tracked through the body. The Abilify MyCite aripiprazole tablets- for treating schizophrenia and manic episodes-have an ingestible sensor embedded inside them that records that the medication has been taken. Mitchell Mathis, from the Food and Drug Administration, said: Being able
12/15/17 - FDA expands labeling on 3D breast exams
A type of breast imaging used by Tidelands Health has been approved by the FDA as the only mammography exam superior to standard 2 D mammography for routine cancer screenings of women with dense breasts. Hologic s Genius 3 D Mammography exam is offered at all Tidelands Health mammography locations. The Genius 3 D exam is the only mammogram clini
12/15/17 - Masimo Announces FDA Clearance and Worldwide Release of NomoLine? Capnography Sampling Lines
By a News Reporter-Staff News Editor at Health& Medicine Week Masimo announced FDA clearance and U.S. release of the full family of NomoLine? capnography sampling lines. NomoLine sampling lines are available in more than 40 configurations of airway adapter sets and cannulas for use in a variety of clinical scenarios, including for intubated and
12/15/17 - Pfizer Announces FDA Approval of XELJANZ (tofacitinib) and XELJANZ XR for the Treatment of Active Psoriatic Arthritis
Pfizer Inc. announced today that the United States Food and Drug Administration has approved XELJANZ 5 mg twice daily and XELJANZ XR extended release 11 mg once daily for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic d
12/14/17 - Allergan Receives FDA Clearance for the CoolSculpting Treatment to Improve Appearance of Lax Tissue in the Double Chin
DUBLIN- Allergan plc today announced that the CoolSculpting treatment is the first and only non-surgical fat reduction technology to be FDA- cleared for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments. 'In my own patients, I have noticed the improved appearance of lax tissue when using the CoolMini ap
12/14/17 - Chemence Medical Receives FDA Clearance for Exofin Fusion Skin Closure System
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 strip, mesh anchors and a fast-curing 2- octyl cyanoacr
12/14/17 - FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
This new indication provides the first FDA- approved therapy specifically to treat EGPA. 'Prior to today's action, patients with this challenging, rare disease did not have an FDA- approved treatment option,' said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Ev
12/14/17 - FDA Approves Short Acting Insulin Drug for Diabetes [Tehran Times (Iran)]
Admelog, a short-acting form of insulin, has been approved by the US Food and Drug Administration to treat patients aged 3 years and older with either type of diabetes. Admelog is the first drug approved as a follow-up product based on an abbreviated new process dubbed 505, the agency said Monday in a news release. A new drug approved this way reli
12/14/17 - gel-e receives US FDA clearance to expand its bandage product line for Rx and OTC use
gel-e Inc., a privately held, clinical-stage medical device company, announces the 510 clearance of its adhesive bandage by the U.S. Food and Drug Administration for prescription and over-the-counter use. This new bandage clearance expands the Company's label to include the management of moderately to heavily exuding chronic wounds and acute woun
12/14/17 - Karolinska Development's portfolio company Promimic receives FDA approval for HAnano Surface for use on dental implants
Karolinska Development announces today that the portfolio company Promimic has received approval from the U.S. Food and Drug Administration for the use of HA Surface as a dental implant coating. "The FDA approval allows for a rapid launch in the United States of dental implants coated with HA Surface- a unique technology that improves the integrat
12/14/17 - Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi? (ozenoxacin) Cream, 1%, a Novel Topical Antibiotic for Impetigo
Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration approved Xepi? Cream, 1%, a new chemical entity for the treatment of impetigo in patients two months of age and older when applied topically twice daily for 5 days. In the U.S., impetigo is estimated to account for approximately 10% of skin problems obs
12/14/17 - Omeros Corporation Announces FDA Approval of OMIDRIA for Use in Pediatric Patients
FDA approved the sNDA for OMIDRIA under priority review. Together with the label expansion now including both pediatric and adult patients, FDA also granted OMIDRIA an additional six months of U.S. market exclusivity. 'We are pleased that FDA has approved the use of OMIDRIA in pediatric patients and granted additional market exclusivity,' said Greg
12/14/17 - Pfizer Biosimilar Medicine IXIFI Gets FDA Approval For All Eligible Indications
NEW YORK CITY- Pfizer Inc. announced that the United States Food and Drug Administration has approved IXIFI or PF-06438179, infliximab-qbtx, a chimeric human-murine monoclonal antibody or mAb against tumor necrosis factor, as a biosimilar to Remicade or infliximab for all eligible indications of the reference product. Pfizer has a portfolio of thre
12/14/17 - Q: What are the possible health risks from artificial sweeteners? How do we know if they're safe?
A: Six artificial sweeteners, also known as "non-nutritive" and "high-intensity" sweeteners, have received FDA approval. It, along with all the other FDA- approved artificial sweeteners except saccharine and aspartame, is heat-stable. Stevia, a sweetener made from the leaf extract of a plant native to parts of South America, gets a Generally Recogn
12/14/17 - Sanofi wins US approval for follow-on Humalog insulin copy [Algeria Press Service]
The US FDA has approved Admelog as a follow-on drug five months after it received European market authorisation as a biosimilar of Eli Lillys Humalog. This was because Sanofi submitted Admelog to the FDA through the 505 pathway, making it a and a follow-on product, spokesperson Anna Robinson said, and not through the dedicated biosimilar 351 pathwa
12/14/17 - Sanofi: PHL approved vaccine-trial protocols [Business Mirror (Philippines)]
The protocols of the trials' satisfied Philippine FDA regulations, and requirements were endorsed by various national agencies and international experts, in full compliance with no less than the Guidelines of the World Health Organization,' Sanofi Pasteur Vice President Thomas Triomphe said on Wednesday. 'The Dengvaxia vaccine offers, and has clear
12/13/17 - Alembic Pharma gains on USFDA approval for Darifenacin [All Iraq News Agency (AIN)]
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application Darifenacin Extended- Release Tablets, 7.5 mg and 15 mg. Alembic Pharmaceuticals, a leading pharmaceutical company, is a market leader in the macrolides segment of anti-infective dr
12/13/17 - Alembic Pharmaceuticals gets USFDA go-ahead for bladder drug [Arab Times (Kuwait)]
Alembic Pharmaceuticals has received US health regulator`s nod for a drug used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency. "The company has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Darifenacin extended release tablets, 7.5 mg and
12/13/17 - Capricor Therapeutics Announces FDA Clearance of Investigational New Drug IND Application for CAP-1002
Capricor believes that if the primary endpoint is reached, the HOPE -2 Trial could serve as a registration trial, meaning that its results could support the submission of a Biologics License Application to obtain marketing approval of CAP-1002. Capricor expects to initiate the HOPE -2 Trial in the first quarter of 2018.. Capricor plans to apply for
12/13/17 - FDA approves admelog for diabetes [Algeria Press Service]
Admelog, a short-acting form of insulin, has been approved by the U.S. Food and Drug Administration to treat patients aged 3 years and older with either type of diabetes. Admelog is the first drug approved as a follow-up product based on an abbreviated new process dubbed 505, the agency said Monday in a news release. A new drug approved this way re
12/13/17 - FDA Approves First Drug for Eosinophilic Granulomatosis With Polyangiitis, a Rare Disease Formerly Known as the Churg-Strauss Syndrome
This new indication provides the first FDA- approved therapy specifically to treat EGPA. "Prior to today's action, patients with this challenging, rare disease did not have an FDA- approved treatment option," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug E
12/13/17 - FDA approves first short-acting, follow-on biologic of Lilly`s Humalog insulin product [Syrian Arab News Agency]
The FDA has announced its approval of Sanofis Admelog, the first follow-on biologic version of Eli Lillys Humalog a short-acting insulin authorised for the improvement of glycaemic control in in adults and children aged three years and older with type 1 diabetes and adults with type 2 diabetes. The data which prompted the decision was derived from
12/13/17 - FDA Approves New Pfizer Biosimilar
Pfizer Inc. announced today that the United States Food and Drug Administration has approved IXIFI?, a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to Remicade * for all eligible indications of the reference product. 1. Pfizer has a portfolio of three marketed biosimilar medicines outside the U.S. inc
12/13/17 - FDA Approves Sanofi's Admelog
Paris, France- The U.S. Food and Drug Administration has approved Sanofi's Admelog, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. 'Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Adme
12/13/17 - GSK Gets FDA Approval For Nucala For Treatment Of EGPA For Adults
LONDON- GlaxoSmithKline plc announced that the US Food and Drug Administration has approved Nucala or mepolizumab as the first targeted treatment for eosinophilic granulomatosis with polyangiitis or EGPA, previously known as Churg-Strauss syndrome. The approval for EGPA is based on results from the pivotal, 52- week, Phase III MIRRA1 study, conduct
Articles(s): 1 - 25 of 64     Next >>     Go To Page:


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