Beecham's amoxicillin/clavulanic acid product Augmentin is indicated for the treatment of infections caused by beta-lactamase-producing strains of six organisms, according to FDA-approved labeling for the drug. The labeling states that Augmentin is "indicated in the treatment of infections caused by susceptible strains of the designated organisms" in: (1) "lower respiratory infection -- caused by beta-lactamase producing strains of Hemophilus influenzae;" (2) "otitis media -- caused by beta-lactamase producing strains of Hemophilus influenzae and Branhamella catarrhalis;" (3) "sinusitis -- caused by beta-lactamase producing strains of Hemophilus influenzae and Branhamella catarrhalis;" (4) skin and skin structure infections -- caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, and Klebsiella spp;" and (5) urinary tract infection -- caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp, and Enterobacter spp. In addition, the package insert notes that other gram positive, gram negative and anaerobic organisms have shown in vitro susceptibility to the drug, although clinical efficacy has not yet been documented. In vitro susceptibility has been demonstrated, the labeling states in both beta-lactamase and non-beta-lactamase producing strains of organisms including Staphylococcus epidermis, Staphylococcus saprophyticus, Bacteroides species including B. fragilis, Proteus mirabilis, Proteus vulgaris, Nesgeria gonorrhoeae, and Legionella. FDA approved the drug, Beecham's first new compound since Ticar (ticarcillin) cleared the agency in 1976, on Aug. 6. Beecham submitted an NDA for the tablet formulation in December 1981 and an NDA for the oral suspension in September 1982. The agency considered the drug a new chemical entity which represents a modest therapeutic gain over current therapies. The labeling explains that "the formulation of amoxicillin with clavulanic acid in Augmentin protects amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibiotic spectrum of amoxicillin and other beta-lactam antibiotics. Thus Augmentin possesses the distinctive properties of a broad spectrum antibiotic and a beta-lactamase inhibitor." Augmentin's clavulanic acid component is "a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins," the labeling says. "In particular, it has good activity against the clinically important plasmid mediated beta-lactamases frequently responsible for transferred drug resistance." The labeling points out that while Augmentin is indicated only for the specific beta-lactamase-producing organisms, "infections caused by ampicillin susceptible organisms are also amenable to Augmentin treatment due to its amoxicillin content." Therefore, the insert continues, "mixed infections caused by ampicillin susceptible organisms and beta-lactamase producing organisms susceptible to Augmentin should not require the addition of another antibiotic." Augmentin's launch is set for mid-September. The drug will carry a list price of $21 for 250 mg tabs and $31.50 for 500 mg tabs in bottles of 30, Beecham said. For the oral suspension dosage form, the list price is $5.15 for 125 mg/75 ml, $10.09 for 150 mg/125 ml, $9.79 for 250 mg/75 ml and $19.19 for 250 mg/150 ml. Discount to whslrs. is 18% less than the list price, the firm noted. Beecham has several other antibiotics in clinicals. Timentin employs the same mode of action as Augmentin, combining clavulanic acid with ticarcillin. Timentin and the topical antibiotic Bactroban (pseudomonic acid) are in Phase III trials. Temocillin is in Phase I and an I.V. form for Augmentin is in Phase II trials.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
