FSC Laboratories Wins FDA Approval For Flexichamber™
FSC Laboratories, Inc. Announces FDA Clearance for Flexichamber™, a Collapsible Anti-static Valved Holding Chamber
CHARLOTTE, N.C.--(BUSINESS WIRE)--FSC Laboratories, Inc. today announced that the FDA has granted clearance for the company’s new collapsible holding chamber, Flexichamber ™, for use by patients under the care or treatment of a licensed healthcare professional, to administer aerosolized medication from most pressurized Metered Dose Inhalers (MDI). Flexichamber is a prescription medical device which will be distributed by FSC Laboratories, Inc., and promoted by its subsidiary, FSC Pediatrics, Inc., to pediatric primary care-focused practitioners and pediatric subspecialists across the U.S.
“We developed Flexichamber, a patented, compact collapsible holding chamber, to address pediatric patient and parent needs by combining the clinical effectiveness expected from the leading hard-sided chambers and the convenience of a device that can easily fit in a pocket, backpack, or purse,” said Peter W. Steelman, President and Chief Executive Officer of FSC Pediatrics.
According to the Centers for Disease Control, asthma affects 25.7 million people in the U.S., including 7.0 million children under the age of 181. “Flexichamber is another important addition to our growing portfolio of pediatric products and continues to demonstrate our commitment to improving the health and well-being of pediatric patients,” said Steelman. Holding chambers help improve delivery of medication to the lungs; help prevent a person from breathing medication too fast; and can make taking medication easier when a patient is having symptoms, according to the American Lung Association2.
Approximately 2.0 million prescriptions are filled annually in the U.S. for holding chambers. Flexichamber is a compact, collapsible chamber which contains a one-way duckbill-shaped valve for inhalation and to prevent patients from exhaling back into the chamber. Flexichamber is comprised of anti-static materials to help improve delivery of medication from MDIs to the patient while minimizing the adherence of the medication to the walls of the chamber. Flexichamber can be used with or without a mask.
About Flexichamber™
Intended Use for Flexichamber (Anti-static Valved Holding Chamber):
Flexichamber™ is a prescription medical device intended to be used by patients, under the care or treatment of a licensed healthcare professional, to administer aerosolized medication from most pressurized Metered Dose Inhalers (MDI). The product is intended for patients who can follow verbal instructions, and environments for use include home, hospitals, and clinics.
Important Information Concerning Flexichamber:
1. Package insert dosing instructions should be consulted for all metered-dose inhalers (MDIs) when used with Flexichamber. Dosage and administration recommendations vary for different MDIs. The limitations and conditions of use for each product should be considered before utilizing this device.
2. Product may need to be replaced after 12 months of use. Proper storage, cleaning, and environmental conditions may affect the product life span.
3. Store in a cool, dry place.
4. Do not share this device with anyone. It is intended for use with a single patient.
5. Do not place in dishwasher. Wash the Flexichamber by hand using lukewarm water and a mild, non-abrasive dish detergent.
For more information about Flexichamber (Anti-Static Valved, Holding Chamber), contact FSC Pediatrics, Inc.
Flexichamber™ is a trademark of FSC Laboratories, Inc.
About FSC Pediatrics
FSC Pediatrics, Inc., a subsidiary of FSC Laboratories, based in Charlotte, NC, is a specialty pharmaceutical and medical device company founded in 2004, solely dedicated to providing innovative solutions to unmet medical needs for pediatric patients. FSC Pediatrics provides products that meet pediatric primary care and specialist needs in the following therapeutic categories: Gastrointestinal, Infection and Allergy/Asthma. More information is available at www.fscpediatrics.com.
References:
1. Centers for Disease Control and Prevention, www.cdc.gov.
2. The American Lung Association, www.lung.org
Contacts
FSC Pediatrics
Paul Feirstein, 704-941-2500
Vice President Marketing and Sales
paulfeirstein@fscpediatrics.com
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CHARLOTTE, N.C.--(BUSINESS WIRE)--FSC Laboratories, Inc. today announced that the FDA has granted clearance for the company’s new collapsible holding chamber, Flexichamber ™, for use by patients under the care or treatment of a licensed healthcare professional, to administer aerosolized medication from most pressurized Metered Dose Inhalers (MDI). Flexichamber is a prescription medical device which will be distributed by FSC Laboratories, Inc., and promoted by its subsidiary, FSC Pediatrics, Inc., to pediatric primary care-focused practitioners and pediatric subspecialists across the U.S.
“We developed Flexichamber, a patented, compact collapsible holding chamber, to address pediatric patient and parent needs by combining the clinical effectiveness expected from the leading hard-sided chambers and the convenience of a device that can easily fit in a pocket, backpack, or purse,” said Peter W. Steelman, President and Chief Executive Officer of FSC Pediatrics.
According to the Centers for Disease Control, asthma affects 25.7 million people in the U.S., including 7.0 million children under the age of 181. “Flexichamber is another important addition to our growing portfolio of pediatric products and continues to demonstrate our commitment to improving the health and well-being of pediatric patients,” said Steelman. Holding chambers help improve delivery of medication to the lungs; help prevent a person from breathing medication too fast; and can make taking medication easier when a patient is having symptoms, according to the American Lung Association2.
Approximately 2.0 million prescriptions are filled annually in the U.S. for holding chambers. Flexichamber is a compact, collapsible chamber which contains a one-way duckbill-shaped valve for inhalation and to prevent patients from exhaling back into the chamber. Flexichamber is comprised of anti-static materials to help improve delivery of medication from MDIs to the patient while minimizing the adherence of the medication to the walls of the chamber. Flexichamber can be used with or without a mask.
About Flexichamber™
Intended Use for Flexichamber (Anti-static Valved Holding Chamber):
Flexichamber™ is a prescription medical device intended to be used by patients, under the care or treatment of a licensed healthcare professional, to administer aerosolized medication from most pressurized Metered Dose Inhalers (MDI). The product is intended for patients who can follow verbal instructions, and environments for use include home, hospitals, and clinics.
Important Information Concerning Flexichamber:
1. Package insert dosing instructions should be consulted for all metered-dose inhalers (MDIs) when used with Flexichamber. Dosage and administration recommendations vary for different MDIs. The limitations and conditions of use for each product should be considered before utilizing this device.
2. Product may need to be replaced after 12 months of use. Proper storage, cleaning, and environmental conditions may affect the product life span.
3. Store in a cool, dry place.
4. Do not share this device with anyone. It is intended for use with a single patient.
5. Do not place in dishwasher. Wash the Flexichamber by hand using lukewarm water and a mild, non-abrasive dish detergent.
For more information about Flexichamber (Anti-Static Valved, Holding Chamber), contact FSC Pediatrics, Inc.
Flexichamber™ is a trademark of FSC Laboratories, Inc.
About FSC Pediatrics
FSC Pediatrics, Inc., a subsidiary of FSC Laboratories, based in Charlotte, NC, is a specialty pharmaceutical and medical device company founded in 2004, solely dedicated to providing innovative solutions to unmet medical needs for pediatric patients. FSC Pediatrics provides products that meet pediatric primary care and specialist needs in the following therapeutic categories: Gastrointestinal, Infection and Allergy/Asthma. More information is available at www.fscpediatrics.com.
References:
1. Centers for Disease Control and Prevention, www.cdc.gov.
2. The American Lung Association, www.lung.org
Contacts
FSC Pediatrics
Paul Feirstein, 704-941-2500
Vice President Marketing and Sales
paulfeirstein@fscpediatrics.com
Help employers find you! Check out all the jobs and post your resume.