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FSC Laboratories, Inc. to Market Cefaclor for Oral Suspension in the U.S.FSC Therapeutics, LLC, today announced that the Company has entered into a transaction with Yung Shin Pharm. Ind. Co., Ltd. to acquire exclusive U.S. marketing rights for Cefaclor for Oral Suspension, 125 mg/5 mL, 250 mg/5 mL and 375 mg/5 mL, for the treatment of otitis media, lower respiratory infections, pharyngitis and tonsillitis, urinary tract infections and skin and skin structure infections, caused by susceptible organisms. Cefaclor for Oral Suspension will be distributed by FSC Laboratories, Inc., and promoted by its subsidiary, FSC Pediatrics, Inc., to pediatric primary care-focused practitioners across the U.S. Cefaclor belongs to the family of antibiotics known as cephalosporins, which are bactericidal agents (they kill susceptible bacteria) that have the same mode of action as other beta-lactam antibiotics (such as penicillins). "Cefaclor is an excellent fit with our current portfolio of products. We have a rich history in the anti-infectives market and the addition of cefaclor further strengthens our commitment to be a trusted advocate for children," said Peter W. Steelman, President and Chief Executive Officer of FSC Pediatrics. Cefaclor is a second-generation cephalosporin antibiotic used to treat certain infections, caused by susceptible bacteria. Cephalosporins are active against specific gram-negative and gram-positive organisms and are grouped into "generations" based on their spectrum of antimicrobial activity. Each newer generation of cephalosporin has significantly greater gram-negative antimicrobial spectrum than the preceding generation, and in most cases decreased activity against gram-positive organisms. Cefaclor for Oral Suspension should only be used to treat infections proven or strongly suspected to be caused by susceptible bacteria. The usual recommended daily dosage for pediatric patients is 20 mg/kg/day in divided doses every 8 hours. In more serious infections, otitis media, and infections caused by less susceptible organisms, 40 mg/kg/day are recommended, with a maximum dosage of 1g/day. About Cefaclor for Oral Suspension INDICATIONS FOR USE: Cefaclor for Oral Suspension is indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:
IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONS: Cefaclor for Oral Suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics. WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: The most frequently occurring adverse reactions related to cefaclor therapy include:
DRUG INTERACTIONS:
USE IN PEDIATRIC PATIENTS:
For more information about Cefaclor for Oral Suspension, click here for the full Prescribing Information. 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: Infection, Gastrointestinal, and Allergy/Asthma. More information is available at www.fscpediatrics.com. Source (News - Alert): FSC Therapeutics, LLC
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