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Bacterial Vaginosis Treatment -, Approval for Additional Indication of Bacterial Vaginosis


Bacterial Vaginosis Treatment -, Approval for Additional Indication of Bacterial Vaginosis
Shionogi & Co Ltd: Officer Antitrichomonal, Flagyl ®, approval for additional indication of bacterial vaginosis
21.03.2012 | 02.10 clock
Antitrichomonal agent, Flagyl ® approval for additional indication of Bacterial Vaginosis Treatment

Osaka, Japan, March 21, 2012 - Shionogi & Co., Ltd. (Headquarters: Osaka, President & CEO: Isao Teshirogi, Ph.D., hereafter "Shionogi") today announced approval for a new indication received from "Flagyl ® 250 mg tablets" and "vaginal Flagyl ® 250 mg" (generic name: metronidazole) for bacterial vaginosis.

The Second Committee on New Drug Law Drug and Food Hygiene Council on 1 August 2011 was held, was assessed on a provisional basis and allowed to present a further indication of Flagyl ®. Shionogi has filed another indication of bacterial vaginosis, August 5, 2011. With regard to this additional indication Flagyl ®, the Research Committee for the unapproved drug and drug use off-label with significant medical needs, which was founded by the Ministry of Health, Welfare and Labor (hereinafter "MHLW"), with the doctor and asked Need MHLW agreed that their development Shionogi.

Shionogi expects Flagyl ® is a new treatment option for patients and medical professionals who bring to the approval of bacterial vaginosis and strives to contribute to the solution of unapproved drugs and drug off-label to .
Forward-Looking Statements

This press release contains forward-looking statements. These statements are based on expectations that are based in light of current information, assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions and changes in interest rates and exchange rate risk.

These risks and uncertainties particularly apply with respect to product-related statements. Involve product risks and uncertainties include, but not to stop the completion and limited clinical testing, obtaining regulatory approvals, claims and concerns about the safety and efficacy, and technological advances, significant adverse resolution of litigation, domestic and foreign health care reforms and changes in laws and regulations. Also for existing products, there are risks of manufacturing and marketing, which include, but are not limited to, the inability to build production capacity to meet demand,

Availability of raw materials and entry of competitive products. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.Bacterial Vaginosis Treatment
Created by melinda molly on 28/03/2012 08:23

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