Navigation Links
Paragon BioTeck, Inc. Announces FDA Approval of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%
Date:3/22/2013

Tigard, OR (PRWEB) March 22, 2013

Paragon BioTeck, Inc., a privately held biopharmaceutical company specializing in the development of ophthalmic pharmaceuticals and therapies, today announced that the U.S. Food and Drug Administration has approved its New Drug Application (NDA) for Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, to dilate the pupil.

“This approval represents an important milestone not only for Paragon, but also within the eye care community as a whole,” said Patrick Witham, President and CEO of Paragon BioTeck. “Phenylephrine Hydrochloride Ophthalmic Solution has been marketed without FDA approval for decades, and during that time has been administered to millions of patients. With the increase in drug manufacturers domestically and abroad, FDA oversight over drug products is more important than ever. The FDA approval process is in place to ensure both that a drug is safe and that it’s manufactured under appropriate controls and oversight.”

About Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly a-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.

Phenylephrine Hydrochloride Ophthalmic Solution Important Safety Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis, as well as in pediatric patients under the age of one due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. It’s for topical ophthalmic use only, and not for injection.

Serio
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related medicine news :

1. hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces Price Match Guarantee for Comparable Medical Weight Loss Plans
2. Number One Provider of Hearing Aids in Medford OR, Imaginears, Announces Launch of New Website
3. Sharon Kleyne Announces Investment into Fresh Water IP Technology
4. Manatee Works Announces Second Generation Mobile Decoding Engine
5. Depression Treatment Center.com Announces 2013 Blog Award Winners
6. Cornell Dubilier Announces Long-Life Ultracapacitors
7. MyoNatural Announces New Offer for Chiropractors and Doctors Offices Around the US
8. MinuteHound Announces Time and Attendance Solutions for Fitness Centers and Chains
9. La Jolla Vein Care Announces that Nisha Bunke-Paquette, M.D., FACPh, Inducted As a Fellow Of The American College Of Phlebology
10. NLN Foundation for Nursing Education Announces 2013 Nursing Education Scholarship Program Promoting Academic Progression
11. Dennis R. Hill MD Announces Launch of High Dose Rate Brachytherapy of Prostate Cancer Website
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2015)... ... ... Isabel Healthcare announced today that it will donate the use of the ... Free Health Clinic. The Isabel diagnosis decision support solution will be used ... their perspective while working up their patients. Isabel will also provide contextual links ...
(Date:6/30/2015)... ... June 30, 2015 , ... New Xarelto lawsuit ... the use of new forms, according to attorneys handling Xarelto lawsuits ... Short Form Complaint, “provide guidance” for plaintiffs’ attorneys in filing new claims, according ...
(Date:6/30/2015)... Petersburg, FL (PRWEB) , ... June 30, 2015 , ... Skin Brushing (also known as ... helpful to keep skin optimal and beautiful as it is more exposed to the elements. ... It can:, , Exfoliate the dead cells and toxins on skin's ...
(Date:6/30/2015)... ... June 30, 2015 , ... ... 2015 amidst bright skies and inspirational words. , The independent, coeducational, special ... from the Glenholme building to the school’s Center for the Arts. Along the ...
(Date:6/30/2015)... ... June 30, 2015 , ... Intellitec Solutions has announced they will be ... CRM. With the enhanced changes and new procedures involved with updating the cloud version ... a look at the new user interface and what it will mean for end ...
Breaking Medicine News(10 mins):Health News:Isabel Healthcare Donates Differential Diagnosis Decision Support Tool to That Neighborhood Foundation 2Health News:Isabel Healthcare Donates Differential Diagnosis Decision Support Tool to That Neighborhood Foundation 3Health News:Xarelto Lawsuit News: New Xarelto Lawsuit Filings to Be Expedited 2Health News:Xarelto Lawsuit News: New Xarelto Lawsuit Filings to Be Expedited 3Health News:Back in Stock: Keep Skin and Lymphatic System Healthy with Dry Skin Brushes from Sublime Beauty® 2Health News:The Glenholme School Graduates Its Class of 2015 2Health News:The Glenholme School Graduates Its Class of 2015 3Health News:The Glenholme School Graduates Its Class of 2015 4Health News:Intellitec Solutions to Host Microsoft CRM 2015 Update Webinar 2
... of exposure set by CDC need to be lowered, experts ... blood lead levels well below those considered safe are still ... researchers report. , Currently, the maximum safe blood level of ... set by the U.S. Centers for Disease Control and Prevention ...
... The online CURE ... of its readers living with cancer to uncover challenges facing patients today and better identify ... East Hanover, ... three patients with rare cancers - twice the number as those with more common cancers ...
... , , , ... with prescription drug coverage are more satisfied with their pharmacy ... those with wholly private insurance, according to the J.D. Power ... , (Logo: http://www.newscom.com/cgi-bin/prnh/20050527/LAF028LOGO-a ) , , ...
... Calif., Sept. 17 DURECT Corporation (Nasdaq: DRRX ) ... healthcare conferences. , , (Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO ) ... Hogan, Chief Financial Officer, will present at the UBS Global Life ... a.m. Eastern Time. A live audio webcast of the presentation ...
... NEOG ) announces the following Webcast: , , , ... When: Thursday, September 24, 2009 @ 11:00 ET, Where: ... Internet -- Simply log on to the web at the, ... of Neogen Corporation, +1-800-234-5333., , , If you are unable ...
... , , , ... to expand its brand, Nutrisystem Inc., (Nasdaq: NTRI ), is ... Diet in Japan. Capitalizing on the success of Nutrisystem branded ... Foods will begin to sell Nutrisystem J Diet in Japan on October ...
Cached Medicine News:Health News:Even Small Amounts of Lead Harmful to Kids 2Health News:Even Small Amounts of Lead Harmful to Kids 3Health News:New Survey Highlights the Challenges of People Living with Rare Cancer 2Health News:New Survey Highlights the Challenges of People Living with Rare Cancer 3Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 2Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 3Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 4Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 5Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 6Health News:J.D. Power and Associates Reports: Among Pharmacy Customers, Satisfaction is Equally as High for the Privately Insured and for Those With Public-Private Insurance 7Health News:DURECT Corporation to Participate in Upcoming Healthcare Conferences 2Health News:Nutrisystem and House Foods Announce Licensing Agreement To Market Nutrisystem J Diet in Japan 2Health News:Nutrisystem and House Foods Announce Licensing Agreement To Market Nutrisystem J Diet in Japan 3
(Date:6/30/2015)... June 30, 2015  Today, the National Mobility Equipment ... 2015 National Mobility Awareness Month Local Heroes Contest on ... online entries that received 1.3 million votes. The sponsors ... Toyota Mobility , and Valley Honda Dealers ... and Vantage Mobility International (VMI) and ...
(Date:6/30/2015)... Calif. , June 30, 2015  Avanir ... PRISM II study showing that treatment with NUEDEXTA ... reduction in symptoms of pseudobulbar affect (PBA) in ... PBA is a distressing condition characterized by sudden ... from certain neurologic diseases or brain injury. PRISM ...
(Date:6/30/2015)... Minn. , June 30, 2015  EnteroMedics Inc. ... devices that use neuroblocking technology to treat obesity, metabolic ... its previously announced public offering  of 40,229,886 units. Each ... of a Series A warrant to purchase one share ... warrant to purchase one share of common stock, at ...
Breaking Medicine Technology:NMEDA Announces National Contest Winners 2NMEDA Announces National Contest Winners 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 2Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 4Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 5Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 6Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 7EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 2EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 3