FDA approves Tamiflu in children younger than 1 year
SILVER SPRING, Md. — The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.
The FDA announced the new approval for Genentech’s Tamiflu (oseltamivir). The agency said that while patients ages 1 year and older can receive the same dosage, those younger than 1 year must be dosed based on their exact weight.
"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," FDA Office of Antimicrobial Products director Edward Cox said. "Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight."
FDA approves new drug for short bowel syndrome
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug to treat a condition that affects people who have had their intestines partially or completely removed, the agency said Friday.
The FDA announced the approval of NPS Pharmaceuticals’ Gattex (teduglutide) for daily injection in adults with short bowel syndrome who need additional nutrition from intravenous feeding. SBS results from partial or complete surgical removal of the small or large intestine, which can lead to poor absorption of fluids and nutrients from food.
Gattex is the third drug for SBS to receive FDA approval. The agency approved Merck KGaA’s Zorbitive (somatropin) in 2003 and Emmaus Medical’s Nutrestore (glutamine) in 2004.
Teva announces $1 billion debt refinancing
JERUSALEM — Teva Pharmaceutical Industries is buying $1 billion worth of its debt, the Israeli drug maker said.
Teva said its finance division, Teva Pharmaceutical Finance IV, had called for redemption of its $1 billion outstanding principal amount of 1.700% senior notes due 2014, funded with proceeds from the company’s offering of $2 billion principal amount of senior notes, priced on Dec. 13, 2012, and closed Tuesday.
The redemption date will be Jan. 7, 2013.
The company also announced that it entered into a new, five-year $3 billion unsecured revolving credit facility, replacing its existing $2.5 billion credit facility.
"By signing this new revolving credit facility, with its increased size and extended term, we took another step on our recently announced new strategy and secured ample liquidity to support Teva’s future growth," Teva chief financial officer and EVP Eyal Desheh said. "We were very pleased to see the significant oversubscription, demonstrating the strong desire from our relationship banks, as well as from additional new banks, to commit to this new facility."