Baxter Announces U.S. FDA Approval and Commercial Launch of Ready-to-Use Clindamycin Injection in Saline
June 07 2017 - 11:00AM
Business Wire
- Only available premixed clindamycin
injection in a saline presentation
- Provides additional access to commonly
prescribed antibiotic in three standard doses
- Premixed presentation can help enhance
patient safety and pharmacy efficiency
Baxter International Inc. (NYSE: BAX), a global leader in
sterile medication production and delivery, today announced the
U.S. Food and Drug Administration (FDA) approval and commercial
launch of ready-to-use clindamycin injection in saline in three
commonly prescribed formulations (300mg/50mL, 600mg/50mL,
900mg/50mL). Baxter made the announcement at the American Society
of Health-System Pharmacists (ASHP) Summer Meetings, taking place
this week.
Clindamycin is a widely prescribed antibiotic for serious
infections caused by susceptible anaerobic bacteria and strains of
streptococci, pneumococci and staphylococci when penicillin is
inappropriate for a patient. For clinicians, clindamycin injection
in saline provides an alternative to administer to patients for
whom the use of dextrose is contraindicated or undesirable.
Baxter’s ready-to-use clindamycin injection in saline is now
available to customers in the United States.
“The addition of clindamycin to Baxter’s portfolio of
ready-to-use premixed medicines reinforces the company’s commitment
to hospital pharmacies and to be a leader in the generic injectable
pharmaceuticals space by providing high-quality, essential
medicines that will benefit patients worldwide,” said Robert
Felicelli, president, Pharmaceuticals, Baxter. “Only Baxter
currently offers clindamycin in saline, making this important
antibiotic suitable for use with a larger patient population.”
Baxter’s differentiated premix portfolio is made possible by a
unique combination of proprietary technical capabilities in drug
formulation, packaging and sterilization. Clindamycin injection in
saline will use Baxter’s proprietary GALAXY container technology, a
non-PVC and non-DEHP system that enables premixed medicines to have
a longer shelf life when stored at room temperature.
Using premixed versions of standard doses of commonly prescribed
drugs can help enhance patient safety by eliminating potential
dosing errors that may occur when medications are compounded, a
process that combines different drug agents in specific quantities
to fill individualized prescriptions to meet a patient’s unique
needs. Manufacturer-prepared premixed drugs are formulated to
adhere to strict Current Good Manufacturing Practice (CGMP)
regulations established and monitored by the FDA. Premixed
medications also offer efficiencies for hospitals by simplifying
the preparation process.
Clindamycin in saline is the third premix from Baxter to receive
FDA approval since August 2015. Baxter remains committed to
providing additional premixes in an effort to advance pharmacy
efficiency and patient care.
INDICATIONS AND USAGE for Clindamycin in 0.9% Sodium Chloride
(clindamycin injection)
Clindamycin is a lincosamide antibacterial indicated for the
treatment of the following:
- Serious infections caused by
susceptible anaerobic bacteria.
- Infections Due to Susceptible Strains
of Streptococci, Pneumococci and Staphylococci.
- Lower Respiratory Tract
Infections.
- Skin and Skin Structure
Infections.
- Gynecological Infections.
- Intra-abdominal Infections.
- Septicemia.
- Bone and Joint Infections.
Limitation of use
Since clindamycin does not diffuse adequately into the
cerebrospinal fluid, Clindamycin in 0.9% Sodium Chloride Injection
should not be used in the treatment of meningitis.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of Clindamycin in 0.9% Sodium Chloride
Injection and other antibacterial drugs, Clindamycin in 0.9% Sodium
Chloride Injection should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria.
IMPORTANT RISK INFORMATION for Clindamycin in 0.9% Sodium
Chloride (clindamycin injection)
WARNING: CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA (CDAD) and
COLITIS
See full prescribing information for complete boxed warning.
Clostridium difficile-associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents, including
Clindamycin in 0.9% Sodium Chloride Injection and may range in
severity from mild diarrhea to fatal colitis. Treatment with
antibacterial agents alters the normal flora of the colon leading
to overgrowth of C. difficile.
Because Clindamycin in 0.9% Sodium Chloride Injection therapy
has been associated with severe colitis which may end fatally, it
should be reserved for serious infections where less toxic
antimicrobial agents are inappropriate. It should not be used in
patients with nonbacterial infections such as most upper
respiratory tract infections.
C. difficile produces toxins A and B which contribute to the
development of CDAD. Hypertoxin producing strains of C. difficile
cause increased morbidity and mortality, as these infections can be
refractory to antimicrobial therapy and may require colectomy.
- Clindamycin injection is
contraindicated in individuals with a history of hypersensitivity
to preparations containing clindamycin or lincomycin.
- Anaphylactic shock and anaphylactic
reactions have been reported.
- Elderly patients with associated severe
illness may have a greater risk of developing adverse reactions
from diarrhea.
- Clindamycin in 0.9% Sodium Chloride
Injection products should be avoided in individuals with a history
of gastrointestinal disease, particularly colitis.
- Clindamycin in 0.9% Sodium Chloride
Injection should be avoided in atopic individuals.
- During prolonged therapy periodic liver
and kidney function tests and blood counts should be
performed.
- The use of Clindamycin in 0.9% Sodium
Chloride Injection may result in overgrowth of non-susceptible
organisms-particularly yeasts.
- Prescribing Clindamycin in 0.9% Sodium
Chloride Injection in the absence of a proven or strongly suspected
bacterial infection or a prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
- Most common adverse reactions:
gastrointestinal (abdominal pain, nausea, vomiting) and
hypersensitivity reactions (anaphylaxis, urticaria, skin
rash).
Please see accompanying full Prescribing
Information.
About Baxter
Baxter provides a broad portfolio of essential renal and
hospital products, including home, acute and in-center dialysis;
sterile IV solutions; infusion systems and devices; parenteral
nutrition; surgery products and anesthetics; and pharmacy
automation, software and services. The company’s global footprint
and the critical nature of its products and services play a key
role in expanding access to healthcare in emerging and developed
countries. Baxter’s employees worldwide are building upon the
company’s rich heritage of medical breakthroughs to advance the
next generation of healthcare innovations that enable patient
care.
This release includes forward-looking statements concerning
clindamycin injection, including expectations with regard to its
availability in the U.S. and benefits associated with its use. The
statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements:
satisfaction of regulatory and other requirements; actions of
regulatory bodies and other governmental authorities; product
quality, manufacturing or supply, or patient safety issues; changes
in law and regulations; and other risks identified in Baxter's most
recent filing on Form 10-K and other SEC filings, all of which are
available on Baxter's website. Baxter does not undertake to update
its forward-looking statements.
BAXTER and GALAXY are trademarks of Baxter International
Inc.
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Baxter International Inc.Media ContactEric Tatro,
224-948-5353media@baxter.comorInvestor ContactClare
Trachtman, 224-948-3085
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