FDA approves generic injectable antibiotic
SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.
The FDA approved Emcure’s vancomycin hydrochloride injection in the 5-g-per-vial strength.
The drug is a generic version of Vancocin, made by ViroPharma.
FDA approves Mylan’s generic version of Detrol LA
SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.
The FDA approved Mylan’s tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.
The drug is a generic version of Pfizer’s Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.
Endo Health Solutions to buy Paladin Labs
MALVERN, Pa. — Endo Health Solutions will acquire Canadian drug maker Paladin Labs for $1.6 billion, mostly in shares of stock, Endo said Tuesday.
Endo said the acquisition would accelerate its efforts to become a global specialty healthcare company, given Paladin’s Canadian business, drug pipeline and business in emerging markets. Paladin, based in Montreal, specializes in drugs for attention deficit hyperactivity disorder, pain, urology and allergies and owns controlling and majority stakes in Mexico-based Laboratorios Paladin and South Africa-based Litha Healthcare Group.
"The acquisition of Paladin Labs accelerates Endo’s transformation from an integrated health solutions company to a top-tier global specialty healthcare leader," Endo president and CEO Rajiv De Silva said. "Together with our sharpened focus, lean operating model and improved execution within our core businesses, strategic acquisitions will continue to play a key role in maximizing our growth potential and cash flow generation to drive future value for Endo shareholders."
As part of the deal, a new holding company based in Ireland, called New Endo, is being created, led by Endo’s current management team. Paladin Labs will continue under its current name and maintain its Montreal headquarters.