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:12/7/2016)... , ... December 07, 2016 , ... "Hacking into my ... had described him as 'a genius.'" Thus begins "Margaret in Berlin," Book Twelve in ... published by Wyston Books, Inc. These novels narrate the lives of a ...
(Date:12/6/2016)... ... December 06, 2016 , ... Men with gum ... risk of serious health problems, such as cardiovascular illness, according to research cited ... Beverly Hills Periodontics & Dental Implant Center notes that the correlation between periodontal ...
(Date:12/6/2016)... ... ... An inventor, from Talladega, Ala., thought there needed to be a more ... , The SLING-VEST provides an effective way to support and align the arm or ... result, it helps to reduce discomfort and shifting. The invention features an effective design ...
(Date:12/6/2016)... ... ... Mount Sinai Health System today announced the creation of the Medical Modeling ... order 3D models for their cases. Virtual reality, simulation, and 3D printing services ... resource will be the first of its kind catering to the unique patient-specific modeling ...
(Date:12/6/2016)... Scottsdale, Arizona (PRWEB) , ... December 06, 2016 , ... ... less than fIve days after launch. Almost 200 backers pledged more than $25,000 ... life-changing technology. , Dr. Amy Serin, an Arizona Neuropsychologist and inventor, ...
Breaking Medicine News(10 mins):
(Date:12/6/2016)...  BTL Aesthetics today announced the release of ... ME device was effectively redesigned for more efficient, ... tissue. The result: Significantly better outcomes in abdominal ... ME versus BTL Vanquish. "We are ... patients with the most highly-advanced devices on the ...
(Date:12/6/2016)... 6, 2016  Arcturus Therapeutics, Inc. ("Arcturus" or ... today that it entered into collaboration with Takeda ... the treatment of NASH and other gastrointestinal (GI) ... LUNAR™ and UNA Oligomer chemistry. The financial terms ... commitment to and expertise in GI disorders, we ...
(Date:12/6/2016)... 6, 2016 A new study released today ... 340B) projects the 340B Drug Pricing Program will continue to ... it is expected to exceed $23 billion in total purchases ... purchases surpass current Medicare Part B drug reimbursement purchases over ... – based on analysis of data on total drug purchases ...
Breaking Medicine Technology: