FDA approves liquid form of Merck HIV drug Isentress for infants, small children
WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.
Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film–coated tablets. The company plans to launch the oral suspension in the third quarter of this year.
"We are very pleased that Isentress can now be a part of a treatment regimen for HIV-1-infected infants and children as young as 4 weeks of age," Merck Research Labs executive director for clinical research Hedy Teppler said.
Fred’s overhauls ops and marketing, explores sale
Regional discount retailer Fred’s is making some big changes to its merchandising and operations groups to begin 2014 and has retained several firms to review strategic opportunities.
On the heels of a 1.4% same-store sales increase in December, driven by its pharmacy business, Fred’s said it had retained BofA Merrill Lynch and Peter J. Solomon Company to review strategic opportunities to enhance shareholder value. In addition, the operator of 701 stores throughout the Southeast, gave CFO Jerry Shore additional responsibilities as COO and said CEO Bruce Efird would lead the merchandising and marketing team and strategy.
"The merchandising and marketing team has been revamped and now will report directly to me,” Efird said. “We have developed new pricing, marketing, inventory management and profit strategies that are designed to drive greater profitability throughout the year, with a key goal of re-energizing fourth-quarter results in 2014.”
In addition, Fred’s will continue to implement the successful elements of a reconfiguration plan, a key aspect of which involves the addition of pharmacies to its discount stores. The company plans 150 to 200 conversions in 2014, which will leave it with pharmacies in 60% of its store by the end of 2014.
The moves come as Fred’s experienced a challenging sales climate throughout 2013. The company’s year-to-date sales increased 1% to slightly more than $1.8 billion, while same-store sales declined 0.9%.
"While December sales were in the range of our expectations, they were driven primarily by the strong performance of our pharmacy department, as the discretionary departments in general merchandising fell short of plan,” Efird said. “The positive impact from our reconfiguration plan continued in December, driven mainly by our hometown auto and hardware department. However, in spite of the success of our reconfiguration program, Fred’s 2013 fourth-quarter promotional strategy, which was centered on Black Friday, did not produce the incremental gains we expected.”
FDA approves generic hypertension pill made by Actavis
DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.
Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.
The drug is a generic version of Boehringer Ingelheim’s Micardis, which had sales of about $274 million during the 12-month period that ended in September, according to IMS Health. As the first company to successfully apply for approval of a generic version, Actavis has 180 days in which to compete exclusively against Boehringer Ingelheim’s product, according to FDA regulations.