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Shionogi Inc. Announces FDA Approval of Cuvposa for the Treatment of Chronic Severe Drooling in Pediatric Patients With Neurologic Conditions(2)
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dosage forms of digoxin.
-- Amantadine: Effects of glycopyrrolate may be increased with
concomitant administration of amantadine. Healthcare providers
should consider decreasing the dose of glycopyrrolate during
concomitant use.
-- Atenolol or metformin: Glycopyrrolate may increase serum levels
of atenolol or metformin. Healthcare providers should consider
dose reduction when used with glycopyrrolate.
-- Haloperidol or levodopa: Glycopyrrolate may decrease serum levels
of haloperidol or levodopa. Healthcare providers should consider
a dose increase when used with glycopyrrolate.
-- Use in Specific Populations
-- Pediatric use: The safety and effectiveness of glycopyrrolate has
not been established in patients under 3 years of age.
-- Renal impairment: Use CUVPOSA(TM) with caution in patients with
renal impairment.
About Shionogi Inc.

Shionogi Inc. is a US-based company of Shionogi & Co., Ltd. Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of patients. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp. For more information on Shionogi Inc., headquartered in Florham Park, NJ, please visit www.shionogi-inc.com.


Forward Looking Statements


This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which 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 of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability 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.


 

 

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