Navigation Links
IGI Laboratories, Inc. Receives Formal US FDA Approval For Site Transfer Of Econazole Nitrate
Date:11/1/2013

BUENA, N.J., Nov. 1, 2013 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received formal approval from the U.S. Food and Drug Administration (FDA) of its supplemental filing for the site transfer of econazole nitrate cream 1%, to the company's manufacturing facility in Buena, NJ.  IGI had purchased econazole nitrate cream 1% from Prasco, LLC in February of 2013. 

(Logo: http://photos.prnewswire.com/prnh/20130827/MM70487LOGO)

Jason Grenfell-Gardner, President and CEO of the Company, commented, "This approval marks the first time the FDA has granted an approval to an IGI own-label project. In less than eight months, we successfully completed all the required steps to achieve approval from the FDA to manufacture our first proprietary IGI label product.  This accomplishment is a testament to the dedication and efforts of our entire team.  We are currently actively manufacturing, marketing and selling this product through our existing commercial infrastructure."

About IGI Laboratories, Inc.

IGI Laboratories is a generic topical pharmaceutical company.  We develop and manufacture topical formulations for the pharmaceutical, OTC, and cosmetic markets. Our mission is to be a leading player in the generic topical prescription drug market.

Forward-Looking Statements

This press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, plans, objectives, expectations and intentions, and other statements contained in this press release that are not historical facts and statements identified by words such as "plan," "believe," "continue", "should" or words of similar meaning. Factors that could cause actual results to differ materially from these expectations include, but are not limited to: our inability to meet current or future regulatory requirements in connection with existing or future ANDAs; our inability to achieve profitability; our failure to obtain FDA approvals as anticipated; our inability to execute and implement our business plan and strategy; the potential lack of market acceptance of our products; our inability to protect our intellectual property rights; changes in global political, economic, business, competitive, market and regulatory factors; and our inability to complete successfully future product acquisitions.  These statements are based on our current beliefs or expectations and are inherently subject to various risks and uncertainties, including those set forth under the caption "Risk Factors" in IGI Laboratories, Inc.'s most recent Annual Report on Form 10-K,  Quarterly Reports on Form 10-Q and other periodic reports we file with the Securities and Exchange Commission.  IGI Laboratories, Inc. does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise, except as required by law.


'/>"/>
SOURCE IGI Laboratories, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. IGI Laboratories, Inc. Announces Twelfth ANDA Submission
2. MO BIO Laboratories, Inc. launches a new kit for isolation of viral nucleic acids from environmental samples
3. Global Vascular Stents Market 2012-2016 Report with Abbott Laboratories, Medtronic Inc. and Boston Scientific Corp. Dominating
4. Charleston Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting on New Migraine Treatment CL-H1T
5. Clontech Laboratories, Inc. Partners With Rubicon Genomics To Increase Speed And Efficiency Of Sample Preparation For RNA Sequencing
6. Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for Intranasal Progesterone
7. FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
8. Antigen Laboratories, Inc. to be Acquired by Ares Life Sciences
9. Positive Data, Pipeline Improvements & Market Expansion - Research Report on Abbott Laboratories, Stryker Corporation, St. Jude Medical, Cardiovascular Systems and MAKO Surgical
10. Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial
11. Charleston Laboratories, Inc. beginnt mit klinischer Phase 3-Studie für CL-108
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... WOONSOCKET, R.I. , Dec. 2, 2016 ... hold its annual Analyst Day in New York City on Thursday, December ... the CVS Health leadership team will provide an in-depth ... and enhance shareholder value. The company will also discuss ... audio and video webcast of the event will be ...
(Date:12/2/2016)... 2, 2016 Orthopedic Implants (Including Spinal ... Expected to Gain a Significant Market Share Owing to a ... ... According to a new report by ... Sterile Packaging: Clamshell Product Type Segment Projected to Witness a ...
(Date:12/2/2016)... N.J. , Dec. 2, 2016   CytoSorbents ... immunotherapy leader commercializing its European Union approved CytoSorb ... and cardiac surgery patients worldwide, announced that Dr. ... the 9th Annual LD Micro Main Event ... , 2016 at the Luxe Sunset Boulevard Hotel in ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... , ... Mediaplanet is proud to announce the launch of ... treatments, therapeutic technologies, and revolutionized nutrition that are helping patients and physicians manage ... in the last 3 decades,” says Dr. Valentine Fuster, a world-renowned cardiologist. “This ...
(Date:12/2/2016)... ... , ... Rijuven Corp launches rejiva ( http://www.rejiva.com ), a unique wearable technology ... health technology on the market can deliver all that rejiva can. , “Rejiva promotes ... their health than the usual heart rate and steps taken”, adds Evens Augustin, CEO ...
(Date:12/2/2016)... ... December 02, 2016 , ... Today ... intelligent, connected applications, was named the best Sales Team of 2016 as part ... was made today by the Software & Information Industry Association (SIIA), the principal ...
(Date:11/30/2016)... ... , ... "I hate when the mixture of saliva and toothpaste runs down ... from Bridgewater, N.J. "I thought that there had to be a way to prevent ... patent-pending DEFLECTOR to prevent saliva and toothpaste from running down the brush handle onto ...
(Date:11/30/2016)... U.K. (PRWEB) , ... November 30, 2016 , ... ... address the tech functions and stylish design wanted by today’s consumers at an ... Cronovo Co-Founder Darin Philip says the new watch is “a game changer” when ...
Breaking Medicine News(10 mins):