FSC Laboratories, Inc. to Market Cefaclor for Oral Suspension in the U.S.

CHARLOTTE, N.C.--()--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


Cefaclor for Oral Suspension is indicated for the treatment of the following infections caused by susceptible strains of the designated microorganisms:

  • Otitis Media due to Streptococcus pneumoniae, Haemophilus influenzae*, staphylococci, and Streptococcus pyogenes
  • Lower respiratory tract infections, including pneumonia, due to Streptococcus pneumoniae, Haemophilus influenzae*, and Streptococcus pyogenes
  • Pharyngitis and Tonsillitis due to Streptococcus pyogenes
  • Urinary tract infections, including pyelonephritis and cystitis, due to Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci
  • Skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes

    *Note: Beta-lactamase-negative, ampicillin-resistant strains of Haemophilus influenzae should be considered resistant to cefaclor.


CONTRAINDICATIONS: Cefaclor for Oral Suspension is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.


  • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactam antibiotics such as cefaclor. If an allergic reaction occurs, discontinue use of Cefaclor for Oral Suspension. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures as clinically indicated.
  • Exercise caution in penicillin-sensitive patients as cross-hypersensitivity with beta-lactam antibiotics has been observed in up to 10% of patients with penicillin allergy.
  • Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotics, including Cefaclor for Oral Suspension, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients presenting with diarrhea after taking antibiotics, and can occur over 2 months after administration of antibiotics. Ongoing antibiotic use not directed against C. difficile may need to be discontinued.
  • Use of Cefaclor for Oral Suspension in the absence of proven or strongly suspected bacterial infection, or for prophylactic use, is unlikely to benefit the patient, and increases the risk of developing drug-resistant bacteria.
  • Prolonged use of cefaclor may result in overgrowth of nonsusceptible organisms. If superinfection occurs during therapy appropriate measures should be taken.
  • Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics.
  • Use with caution in patients with impaired renal function. Cephalosporins have been implicated in triggering seizures in these patients particularly when dosage is not reduced.
  • As with other beta-lactam antibiotics, renal secretion of cefaclor is inhibited by probenecid.
  • Exercise caution in patients with history of gastrointestinal disease, particularly colitis.


The most frequently occurring adverse reactions related to cefaclor therapy include:

  • Gastrointestinal symptoms, including diarrhea (2.5%)
  • Hypersensitivity reactions including morbilliform eruptions (1.5%)
  • Serum-sickness-like reactions (≤0.5%)


  • Probenecid interferes with renal secretion of cefaclor, therefore co-administration with Cefaclor for Oral Suspension is not recommended.
  • Increase in anticoagulant effect may occur when cefaclor is used concomitantly with oral anticoagulants.


  • Safety and effectiveness of cefaclor has not been established in pediatric patients less than 1 month of age.

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: FSC Therapeutics, LLC


FSC Pediatrics
Paul Feirstein, 704-941-2500
Vice President Marketing and Sales


FSC Pediatrics
Paul Feirstein, 704-941-2500
Vice President Marketing and Sales