Lupin gets green light from FDA for generic Hyzaar, Cozaar
BALTIMORE, Md. Lupin Pharmaceuticals received regulatory approval last week for its generic antihypertensive agents, the drug maker said.
Lupin was granted final approval for hydrochlorothiazide-losartan potassium and losartan potassium, the generic versions of Merck’s Hyzaar and Cozaar.
Hyzaar and Cozaar had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data for the 12 months ended in June.
Warner Chilcott’s Atelvia receives FDA approval
ARDEE, Ireland The Food and Drug Administration has approved a new formulation of a drug for osteoporosis made by Warner Chilcott, the drug maker said Monday.
Warner Chilcott announced the approval of Atelvia (risendronate sodium), a treatment for postmenopausal osteoporosis, which it plans to launch early next year. The drug is a delayed-release formulation of Actonel.
“The approval of Atelvia represents an exciting addition to the Actonel franchise, as well as our women’s healthcare product portfolio,” Warner Chilcott president and CEO Roger Boissonneault said. “We believe the dosing convenience of Atelvia sets it apart from other treatment options for osteoporosis patients, and provides an opportunity to regain market share in the United States in this segment.”
Tylenol gets ‘precise’
NEW YORK McNeil Consumer Healthcare recently parlayed its Tylenol brand franchise into external analgesics.
Labeled Tylenol Precise, McNeil introduced two SKUs into the external analgesic space — a patch and a cream. The air-activated heat therapy will go up against Pfizer Consumer’s Thermacare, which is experiencing a resurgence in sales under its relatively new stewardship (Wyeth Consumer, now part of Pfizer, had purchased the rights to Thermacare from Procter & Gamble two years ago).
Both the Tylenol Precise cream and Tylenol Precise patch retail for around $7.99.