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.”
Alcon introduces new lubricant eye drops
HUENENBERG, Switzerland Alcon on Monday announced the launch of Systane Balance lubricant eye drops, formulated with HP Guar, borate, sorbitol, propylene glycol and Alcon’s exclusive LipiTech System — an emulsion technology of mineral oil and an anionic phospholipid. The new eye drop is designed to restore the lipid layer and the natural tear film to allow for relief of dry-eye symptoms.
“We are dedicated to applying scientific rigor to discover treatments for chronic conditions, such as dry eye,” stated Sabri Markabi, Alcon chief medical officer and SVP research and development. “[For example], meibomian gland dysfunction is a significant cause of dry eye symptoms, and now patients who suffer from dry eye associated with MGD can use Systane Balance to restore their lipid layer, re-establish their natural tear film and maintain their tear film stability.”
MGD is the most common cause of evaporative dry eye, with an estimated 50% of dry-eye patients experiencing MGD. Physicians observed an association between the use of Systane Balance and better tear film stabilization, as well as an improvement in the thickening of the lipid layer, which are desirable characteristics in treating dry eye. Unlike some other drops where blurring may be a concern, patients reported minimal blur after instilling drops of Systane Balance, the company stated.