PHARMACY

FDA commissioner blogs regarding challenges facing Indian drug manufacturers

BY Michael Johnsen

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

"I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act — reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012," Hamburg reported. "As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs."

Participants of the roundtable meetings last week attended by Hamburg, which were organized by the Federation of Indian Chambers of Commerce and Industries also reported they were challenged by heightened inspectional activities. "I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality," Hamburg said. "I am pleased that as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the United States adhere to established quality standards," she added. "On the home front, we at the FDA also will continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product."

 

 

 

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Doxercalciferol now available from Roxane Labs

BY Ryan Chavis

COLUMBUS, Ohio — Roxane Labs on Tuesday announced the introduction of doxercalciferol capsules, available in strengths of 0.5-mcg, 1-mcg, and 2.5-mcg in 50-count bottles for immediate shipment to wholesalers and pharmacies across the nation.  

Doxercalciferol is used to lower elevated parathyroid hormone levels in patients who undergo kidney dialysis. Roxane Labs’ doxercalciferol capsules is AB Rated in the Food and Drug Administration Orange Book to Hectorol (doxercalciferol) capsules, 0.5-mcg, 1-mcg, and 2.5-mcg.

Annual sales of doxercalciferol capsules are approximately $48.7 million.

 

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Novartis acquires CoStim Pharmaceuticals

BY Michael Johnsen

BASEL, Switzerland — Novartis on Monday announced that it is broadening its cancer immunotherapy research program with the acquisition of CoStim Pharmaceuticals, a Cambridge, Mass.-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer.

Increasing evidence points to the role of the immune system in controlling cancer and to opportunities for creating effective oncology therapies for cancer patients by stimulating a targeted immune response. Already leading in cancer immunotherapy, with investigative chimeric antigen receptor technology being developed in collaboration with the University of Pennsylvania, with this acquisition Novartis has added late discovery stage immunotherapy programs directed to several targets, including PD-1. These medicines could benefit patients by circumventing cancer’s ability to develop resistance against current single drugs.

"Therapy for many types of cancers are expected to increasingly rely upon rational combinations of agents," stated Mark Fishman, president of the Novartis Institutes for BioMedical Research. "Immunotherapy agents provide additional arrows in our quiver for such combinations. They complement our extensive portfolio of drugs that hit genetically defined cancer-causing pathways, and also may be relevant to expansion of CAR therapies."

Financial terms were not disclosed.

 

 

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