FDA approves new topical treatment of head lice
ROCKVILLE, Md. The Food and Drug Administration has approved a new prescription topical medication for treating head lice, the agency announced Thursday.
Sciele Pharma’s Benzyl Alcohol Lotion, 5% is the first head lice treatment approved by the FDA that uses benzyl alcohol as its active pharmaceutical ingredient. It is meant for patients ages 6 months and older.
“Head lice are a problem that impacts more than 1 million children each year and is easily transmitted to others,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This drug is an effective first-line treatment to eliminate lice infestation and minimize disruption in the daily routines of families.”
Sales and earnings updated at Walmart
BENTONVILLE, Ark. Health and wellness was among the top performing categories at Walmart during March, and combined with a strong start to Easter, it was enough for the company to indicate first-quarter sales and earnings would be at the high-end of the previously communicated range.
The home and grocery categories also were credited with helping the company’s U.S. stores division achieve a 0.6% same-store sales increase. That’s not a large number on a stand-alone basis, and it was below analysts’ expectation. Walmart, however, was quick to point out that results were negatively affected by a significant swing in the timing of Easter, which falls on April 11 this year, compared with March 23 last year. As a result of the shift, the majority of seasonal sales associated with Easter are likely to be reflected in April results.
Walmart was aggressive in its pursuit of Easter seasonal sales this year, and directly targeted the chain drug channel in a national television campaign that portrayed Walmart as a less expensive alternative for Easter products. In addition, the company continued to promote its $4 generic drug program on the cover of a circular distributed the week of March 29.
“Based on the initial strength of our sales this week, we expect Easter to drive April sales performance,” said Walmart vice chairman Eduardo Castro-Wright. “Clarity of offering, quality brands, unbeatable prices and strong operational execution are driving growth in multiple categories.”
When March results are combined with actual results from February and anticipated results for April, Walmart expects total U.S. same store sales to be around the high end of a previously forecast range of 1% to 3% for the first quarter. As a result of the sales momentum and what cfo Tom Schoewe called, “expense control,” the company indicated first quarter earnings per share would be toward the high end of the range of $0.72 to $0.77 provided in February.
“We remain well positioned for today’s economy,” Castro-Wright said. “People are choosing to spend money in key discretionary categories across the stores, and this is translating to improvement is several areas of our business, including home.”
Shares of Walmart opened sharply lower from the prior day’s close of $52.61 despite the company’s assertion that once results for April are tallied sales and earnings would be at the high-end of earlier guidance.
FDA denies BioAlliance Pharma’s NDA for Loramyc
PARIS BioAlliance Pharma SA, the specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and AIDS, announced that the FDA did not accept the NDA for Loramyc (miconazole) mucoadhesive buccal tablet to be filed, based on the lack of a tablet imprint code.
Loramyc was approved in Europe in 2007 and is currently marketed in several EU territories including France, Germany, the UK, Sweden, Finland and Denmark.
While the EU does not require a unique tablet identifier, the U.S. FDA does require a tablet imprint code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill this requirement. BioAlliance will work closely with the FDA on the introduction of the debossed tablet and will soon after resubmit the Loramyc application.