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:5/25/2016)... , May 25, 2016 ... Market by Type (3D, 2D, 4D), by Therapeutic Area ... by End User (Medical Device Manufacturers, Hospitals/ Clinics) - ... the global Medical Animation Market for the forecast period ... reach USD 301.3 Million by 2021 from USD 117.3 ...
(Date:5/25/2016)...  Zymo Research Corp. announced today the final ... that help researchers obtain the most accurate and ... rapid growth of the study of microbiomes has ... methods to improve the reproducibility and quality of ... every step of the measurement process including collection ...
(Date:5/25/2016)... 2016 As illustrated by the ... month, the numbers and momentum of cannabis in the ... the billions, more research and development push the sector ... of Legal Marijuana Markets Report  from from ArcView Market ... of the increase in sector is attributed to adult ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses ... human interest stories, courtesy of leaders in the nursing and health care industry. ... from leading advocates and associations—namely Jones & Bartlett Learning. , Jones & Bartlett ...
(Date:5/27/2016)... ... ... With a team of certified experts, Validation Center is ... GMP accreditation, Validation Center is also a registered authority of the international system ... Validation Center is ISO17025 accredited and only offers its clients the latest technology, ...
(Date:5/26/2016)... ... May 26, 2016 , ... W.S. Badger Co. Inc ., the maker ... 2016 When Work Works Award for its use of effective workplace strategies to increase ... Works project administered by the Families and Work Institute (FWI) and the Society for ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... property (IP) to its specialty academic programs. , Answering to the increasing demand ... certificate programs in health law, and environmental and land use law. ,  , ...
(Date:5/26/2016)... ... , ... The Woodlands at John Knox Village , Florida’s first Life ... living and healing, celebrated its grand opening, today. The Woodlands at John Knox Village ... Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village as ...
Breaking Medicine News(10 mins):