PHARMACY

Xellia rolls out vancomycin

BY Sandra Levy

Xellia Pharmaceuticals, a manufacturer of specialty anti-infective treatments, is launching vancomycin hydrochloride for injection.

Vancomycin injection is used to treat infections in many different parts of the body.

“As a leading global supplier of vancomycin API, we are excited to now offer vancomycin 1 g and 10 g in the United States from our vertically integrated supply chain and significant injectable manufacturing footprint,” Xellia North America president Craig Boyd said. “This is the first of many key launches that will bring Xellia’s strong portfolio of established and innovative products to patients in need of critical anti-infective treatments.”

The product had a market value of $338 million for the 12 months ending August 2018, according to IQVIA.

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Cipla gets FDA OK for generic Valcyte

BY Sandra Levy

Cipla has received the Food and Drug Administration’s green light for valganciclovir tablets in a 450 mg dosage strength.

The product, which is a generic version of Roche’s Valcyte, is a deoxynucleoside analogue cytomegalovirus, or CMV DNA polymerase inhibitor, indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome, and prevention of CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk.

The product had a market value of approximately $79 million for the 12-month period ending September 2018, according to IQVIA.

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Amgen’s Kyprolis’ new dosing option gets FDA nod

BY Sandra Levy

The Food and Drug Administration has approved Amgen’s Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone — once-weekly Kd70 — for patients with relapsed or refractory multiple myeloma.

“In the fight against multiple myeloma, we are committed to continued evidence generation and innovation to serve patients. Kyprolis now offers patients with relapsed or refractory multiple myeloma the option of a more convenient dosing regimen that provides better outcomes with a comparable safety profile,” Amgen executive vice president of research and development David Reese said. “We’re pleased that the FDA has recognized the importance of bringing more treatment options to cancer patients more quickly through its pilot programs, and proud to participate with this Kyprolis data.”

“While great progress has been made in the last decade, multiple myeloma remains an incurable disease characterized by a recurring pattern of remission and relapse, and it is important that patients have treatment options that meet their individual needs,” David Siegel, chief of the division of multiple myeloma at John Theurer Cancer Center at Hackensack University Medical Center, said. “The availability of a more convenient once-weekly dosing regimen, with superior efficacy, comparable safety and longer duration of therapy versus the twice-weekly regimen studied in the trial could allow patients to spend more time outside of the infusion center.”

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