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:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. ... articles published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. ...
Breaking Medicine News(10 mins):