PHARMACY

Taro receives FDA approval for generic Aldara

BY Alaric DeArment

HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

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Keryx, Torii commence phase-3 trial for Zerenex in Japan

BY Alaric DeArment

NEW YORK — A U.S. drug maker and its Japanese partner have started a late-stage clinical trial of a drug for treating elevated phosphate levels in the body, the two announced Monday.

Keryx Biopharmaceuticals and Torii Pharmaceutical, the pharmaceuticals subsidiary of Japan Tobacco, started a phase-3 trial of Zerenex (ferric citrate) in Japan for patients with hyperphosphatemia. The drug also is in phase-3 trials in the United States as a treatment for hyperphosphatemia in patients with end-stage kidney disease on dialysis.

“We congratulate our partner, JT/Torii, on the initiation of the phase-3 program in Japan and are excited by their progress,” Keryx CEO Ron Bentsur said. “We believe that this serves to further validate the commercial potential for Zerenex worldwide.”

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Lilly receives complete response letter for liprotamase

BY Alaric DeArment

INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

The FDA issued a complete response letter to Lilly related to its application for liprotamase, a pancreatic enzyme replacement therapy for exocrine pancreatic insufficiency, requesting that the drug maker conduct an additional clinical trial before resubmitting its application. The FDA issues a complete response letter when it has finished reviewing the application for a drug, but issues remain that preclude final approval.

“Lilly is looking forward to further discussion with the FDA to address the items outlined in the letter and provide the requested information as quickly as possible,” Lilly VP autoimmune, bone-muscle-joint and liprotamase product development Eiry Roberts said. “We are committed to working with the agency and the cystic fibrosis community to make this important treatment available to patients.”

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