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FDA issues complete response for Injectafer

Luitpold Pharmaceuticals Inc., a unit of Daiichi Sankyo Co. Ltd. (Tokyo:4568, Osaka:4568), said FDA issued a complete response letter for an NDA for Injectafer ferric carboxymaltose to treat iron defi...

Luitpold Pharmaceuticals, Inc. Receives Complete Response Letter for Injectafer from the U.S. Food and Drug Administration

Shirley, NY (July 26, 2012) – Luitpold Pharmaceuticals, Inc. had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Injectafer ® (ferric carboxymaltose...

Oral Azacitidine Safe, Effective in Low-Risk MDS

ATLANTA (MedPage Today) -- Oral azacitidine (Vidaza) given for up to 21 days per 4-week cycle for myelodysplastic syndrome appeared safe and effective in patients with lower-risk disease, a researcher...

Azacitidine induction helps stem-cell transplant for myelodysplastic syndrome

NEW YORK (Reuters Health) - Survival after allogeneic stem-cell transplantation for myelodysplastic syndrome (MDS) is just as good with pretransplant azacitidine as with standard -- but more toxic...

Luitpold Pharmaceuticals, Inc. Receives Complete Response Letter for Injectafer(R) from the U.S. ...

Luitpold Pharmaceuticals, Inc. receives complete response letter for Injectafer® from the U.S. FDA

Luitpold Pharmaceuticals submitted a New Drug Application to the U.S. FDA...

Vidaza azacitidine: Phase II data

Oral azacitidine: Interim Phase I data

Azacitidine-associated Sweet's syndrome.

Purpose Sweet's syndrome (also known as acute febrile neutrophilic dermatosis) in two patients receiving azacitidine therapy is reported. Summary The development of Sweet's syndrome in association wit...

Interstitial Lung Disease Associated With Azacitidine Use: A Case Report.

Azacitidine is a pyrimidine nucleoside analog licensed for treatment of adult patients with myelodysplastic syndrome. Azacitidine acts as an inducer of cell differentiation by causing demethylation an...

Activity of azacitidine in chronic myelomonocytic leukemia.

Hypomethylating drugs are useful in the management of myelodysplastic syndrome (MDS). Two of these drugs, azacitidine and decitabine, have received FDA approval for the treatment of MDS and chronic my...

Azacitidine might be beneficial in a subgroup of older AML patients compared to intensive chemotherapy: a single centre retrospective study of 227 consecutive patients.

BACKGROUND: Treatment options in older acute myeloid leukaemia (AML) patients include intensive chemotherapy, best supportive care (BSC), and hypomethylating agents. Currently, limited data is availab...

Phase I study of oral azacitidine in myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia.

PURPOSE To determine the maximum-tolerated dose (MTD), safety, pharmacokinetic and pharmacodynamic profiles, and clinical activity of an oral formulation of azacitidine in patients with myelodysplasti...