Taro submits Flo-Pred application to FDA in new PLR format
WASHINGTON Taro Pharmaceuticals applied Thursday to the Food and Drug Administration seeking approval for its new oral solution, Flo-Pred.
Flo-Pred (prednisolone acetate oral suspension) is an anti-inflammatory or immunosuppressive agent indicated for a variety of diseases and conditions, including allergic, dermatologic, gastrointestinal and hematologic.
The medication also enjoys the distinction of—pending approval—being the first oral steroid label in the FDA’s new physician labeling rule format. The PLR format, which went into effect June 19, requires new content, new structure and new highlights information, as compared to the former structured product labeling.
House passes Defense bill with TRICARE intact
ALEXANDRIA, Va. A new move in Congress to preserve access to community pharmacies for military families drew quick praise today from the National Association of Chain Drug Stores.
NACDS applauded passage in the U.S. House of Representatives on Wednesday of H.R. 4986, a newly revised version of the National Defense Authorization Act for Fiscal Year 2008. The bill is similar to the Defense Authorization Act that was vetoed by President Bush, who objected to a provision related to funding for the Iraqi government. As such, it retains important provisions related to the TRICARE pharmacy program.
Those provisions have long been actively supported by retail pharmacy groups. Among them, the revised bill extends the current freeze on increases to retail pharmacy co-payments. That extension provides a more level playing field between retail and mail-order pharmacy by easing the penalty military members and their dependents once incurred for choosing a community pharmacy over the mail-order provision offered by TRICARE.
The bill passed by the House yesterday also provides that the Department of Defense may negotiate with drug manufacturers for federal pricing discounts for TRICARE prescriptions filled at retail pharmacies, in the same manner as they do today for TRICARE prescriptions filled at military bases or by mail order.
According to Congressional Budget Office estimates, giving TRICARE administrators the power to negotiate drug prices will provide save the government $300 million in fiscal 2008, and $1.8 billion in savings in fiscal years 2008-2012.
“As Yogi Berra said, ‘It’s deja vu all over again.’ We applaud the House for its quick action to revise and re-pass the Defense Authorization Act while keeping its pharmacy-related provisions intact,” said NACDS president and chief executive officer Steve Anderson. “Keeping equal access to community pharmacy for our military men and women is a priority for NACDS.
“This legislation will help maintain choice for soldiers, military retirees, and their families,” Anderson said.
The Defense Authorization Act still faces a vote in the Senate and White House scrutiny.
PL Developments acquires PAL Labs’ manufacturing facility
WESTBURY, N.Y. PL Developments has acquired the assets of PAL Laboratories, which owns a manufacturing facility in Florida focused on the production of pharmaceutical, over-the-counter and nutritional tablets, caplets, and two-piece hard-shell capsules, which PL will use to create a new subsidiary.
This new acquisition will allow for the formation of a new PL Developments’ subsidiary, Avema Pharma Solutions. Avema will focus on developing and manufacturing new products for the pharmaceutical, OTC, and nutritional markets. The facility, which is in current good manufacturing practices, will allow Avema to partner with pharmaceutical companies to develop, manufacture, package, and distribute products for the companies to market.
According to Mitchell Singer, president and chief executive officer of PL Developments, “This acquisition is exciting for everyone at PL Developments. We believe that the synergies between the two companies are substantial. This FDA inspected facility will allow us to develop and manufacture exciting new Rx/OTC products that we will be able to deliver to our retail partners such as Wal-Mart, Costco, CVS and Walgreen’s.”