ECR launches Zolpimist
AMITYVILLE, N.Y. — Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.
ECR announced Friday the launch of Zolpimist (zolpidem tartrate) oral spray. The drug comes in units that provide 60 metered sprays, administering 5-mg or 10-mg doses of the active ingredient. As a hypnotic agent, the drug is classified as a CIV controlled substance by the federal government.
“Zolpimist is a significant addition to ECR, our branded products subsidiary, and reflects our continuing commitment to build this segment of our business through the marketing of widely used, innovative products,” Novadel Pharma CEO Steven Ratoff said. Novadel developed the drug.
Alimera reports positive results of phase-3 study for Iluvien
ATLANTA — A drug designed to treat an eye condition caused by diabetes may provide a long-term option for patients, according to Alimera Sciences.
Alimera said in two three-year, phase-3 pivotal clinical trials — collectively known as the FAME Study — of Iluvien, which is designed to treat diabetic macular edema, the drug improved visual acuity among patients.
"This consistent response rate at month 24 and month 36, with a peak rate of 31.4% in month 30, is encouraging, and we believe demonstrates that Iluvien can provide a long-term option for the treatment of DME for up to three years," said Dan Myers, president and CEO of Alimera Sciences.
Alimera said the company will submit the data to the Food and Drug Administration, following a complete response letter it received from the agency in December 2010.
Generics, specialty drugs drive AmerisourceBergen’s Q1
VALLEY FORGE, Pa. — AmerisourceBergen on Friday reported revenue of $19.9 billion, up 2.9%, for the first quarter ended Dec. 31.
"In the December quarter, we delivered outstanding performance on top of exceptional performance last year,” stated David Yost, AmerisourceBergen CEO. “We had strong results in all of our business units, we benefited from successful generic drug launches and we continued to demonstrate expense and working capital discipline,” he said. "Our balance sheet remains strong, and we continue to have excellent financial flexibility. We are off to a solid start for the fiscal year, demonstrating the strength of our two growth drivers — generics and specialty pharmaceuticals."
AmerisourceBergen reaffirmed its expectations for fiscal year 2011 diluted earnings per share in the range of $2.31 to $2.41.