Navigation Links
KV Pharmaceutical's Launch of Gestiva(TM) Delayed
Date:1/26/2009

ST. LOUIS, Jan. 26 /PRNewswire-FirstCall/ -- KV Pharmaceutical (NYSE: KVa/KVb) has been notified that the pending New Drug Application (NDA) for Gestiva(TM) (alpha hydroxyprogesterone caproate) will not be approved by the U.S. Food and Drug Administration (FDA) until further conditions are met.

As previously disclosed, KV Pharmaceutical entered into a purchase agreement to acquire the U.S. and worldwide rights to Gestiva upon approval of the pending NDA, which was under review by the FDA. The Company previously announced that the date on which the FDA was expected to issue a decision was January 25, 2009.

The Company has been informed by the current NDA applicant that the FDA will not approve Gestiva until additional data and information is submitted and accepted. The NDA applicant and the Company have agreed to certain FDA- suggested revisions to the protocol for a post-approval clinical trial that the parties had previously agreed to conduct. However, the agency has now concluded that an additional condition for approval, among others, will be that a portion of the study subjects must be enrolled in the study prior to final approval. As a result, the Company does not anticipate that it will generate revenues from sales of Gestiva during this fiscal year, which ends on March 31, 2009.

About KV Pharmaceutical Company

KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology- distinguished branded and generic/non-branded prescription pharmaceutical products. The company markets its technology distinguished products through ETHEX Corporation, a national leader in generic pharmaceuticals and Ther-Rx Corporation, its branded drug subsidiary.


'/>"/>
SOURCE KV Pharmaceutical
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine news :

1. Perrigo Company Appointed Generic Distributor by Medimetriks Pharmaceuticals
2. University Medical Pharmaceuticals Appoints Tom Roche as Senior Vice President, Global Sales and Marketing
3. Amylin Pharmaceuticals to Webcast Year-End Results
4. Renhuang Pharmaceuticals, Inc. Engages New Independent Auditor
5. NUCRYST Pharmaceuticals appoints a new director
6. Access Pharmaceuticals Provides an Update on Advances In Its Cobalamin(TM) Oral Drug Delivery Product Development
7. S&R Communications Group Partners With Ovation Pharmaceuticals to Launch Xenazine* (tetrabenazine)
8. Dana-Farber Researcher Named Millennium Pharmaceuticals Career Development Scholar of The Leukemia & Lymphoma Society
9. Alexion Pharmaceuticals To Report Fourth Quarter and Full Year 2008 Results on February 12, 2009
10. Alseres Pharmaceuticals, Inc. Receives Notice of Non-Compliance with Continued Listing Requirements
11. Medimetriks Pharmaceuticals Launches Companys First Prescription Brands
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... DevOps and Agile Software Development, has been awarded a contract by the Center ... Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... a leader in post-acute health care, have expanded their existing home health joint ... Health. , AccentCare has been operating a joint venture home health company with ...
(Date:10/12/2017)... ... ... HMP , a leader in healthcare events and education, today announced that ... ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie & Ozzie Awards luncheon ... editorial and design excellence across a range of sectors. This year’s program included the ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... 2017  Commended for their devotion to personalized service, SMP ... number one in the South Florida Business Journal,s 50 Fastest-Growing ... yearly list, the national specialty pharmacy has found its niche.  ... will soon be honored by SFBJ as the 2017 Power ... Set to receive his award in October, Bardisa said of ...
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
Breaking Medicine Technology: