Sivextro receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration announced that it has approved Sivextro (tedizolid phosphate), an antibacterial drug.
Sivextro is approved to treat patients with acute bacterial and skin structure infection caused by certain susceptible bacteria like staphylococcus aureus — including methicillin-resistant strains (MRSA) and methicillin-susceptible strains — various streptococcus species, and enterococcus faecalis. The drug is available for both intravenous and oral use.
“Today’s approval provides physicians and patients with a new treatment option for serious skin infections,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Sivextro is marketed by Cubist Pharmaceutical, which is based in Lexington, Mass.
Nexcare features tough-as-nails Nana in latest ad campaign
ST. Paul, Minn. — Nexcare, a brand from 3M, announced the launch of "Will It or Won’t It," a new digital campaign that highlights the performance of Nexcare Waterproof Bandages.
The 30-second videos follow Nexcare Nana as she conducts a variety of dramatic product tests, which put her in a variety of oddball scenarios that range from dumpster diving to tackling a high-pressure fire hose.
“‘Will It or Won’t It’ is a first-of-its-kind campaign for Nexcare Brand, and the dramatization further propels our effort to drive a shift in the way people think about the bandages they purchase and how they can be used in everyday-life,” said Joe Green, Nexcare brand manager.
The "Will It or Won’t It" series inspired the "Tough as Nana" sweepstakes, which celebrates the Nana character and gives consumers the opportunity to nominate special people in their lives who are as daring as Nexcare Nana. The brand’s Facebook fans will have a chance to win 1-of-3 trips inspired by the character. Consumers looking to enter the sweepstakes can visit Nexcare.com/Nana.
Westport Pharmaceuticals supports ‘fast-acting’ claims for its Zephrex-D
NEW YORK — The National Advertising Division last week determined that Westport Pharmaceuticals, maker of Zephrex-D nasal decongestant tablets, can support the claims challenged before NAD by Acura Pharmaceuticals, the maker of Nexafed, a competing product.
According to the challenger, the pseudoephedrine in traditional decongestants often provides the chemical precursor to methamphetamine production. Both Nexafed and Zephrex-D are specially formulated to resist extraction and conversion to meth. Such products, the challenger noted, can represent a major advance in public health and safety, but only if they remain effective when used as directed to treat patients’ nasal congestion symptoms.
The challenger argued that the formulation of Zephrex-D reduces its therapeutic efficacy and that, contrary to the advertiser’s claims, Zephrex-D does not provide “full efficacy” or “fast acting … 30-minutes” onset of relief.
The advertiser provided no direct clinical relief studies of Zephrex-D to support the 30-minute claim. However, the advertiser did present evidence regarding bioavailability that reliably demonstrated Zephrex-D would, within 30 minutes of dosing, reach blood levels associated with onset of action and that blood levels would remain in the “maximum effect” range for the duration of the dosing period.
Following its review of the evidence in the record, NAD determined that the advertiser established a reasonable basis for its claims that Zephrex-D “starts working to clear swollen nasal passages in as little as 30 minutes,” is “fast-acting, going to work in as little as 30 minutes,” and provides “fast, effective relief.” NAD further determined that the advertiser established a reasonable basis for its “maintains full efficacy providing necessary clinical benefits for patients” claim.
NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.