The samples for analysis were fluorinated pharmaceuticals consisting of fluorometholone, flutamide, sodium flurbiprofen (USP-Standard, Rockville, MD, USA), flumazenil, flunitrazepam (Hoffmann-La Roche, Grenzach-Wyhlen, Germany), fluvastatin sodium hydrate (Hemofarm, Vrsac, Serbia), fluprednidene acetate (Alcon-Pharma, Freiburg, Germany), fluphenazine dihydrochloride (from the former pharmaceutical company Byk-Gulden, Konstanz, Germany), fluoxetine hydrochloride (Teva, Ulm, Germany), fludarabine phosphate (CRS-standard from EDQM, Strasbourg, France), flurazepam hydrochloride (Roche Diagnostics, Mannheim, Germany), flucytosine (Sigma-Aldrich, Taufkirchen, Germany), and fluconazole (Dr.
Spectral Buffer Signal, width Compound pH ppm SW, ppm Fluphenazine dihydrochloride 1.90 -62 95 Fluoxetine HCl 1.90 -61 95 Fludarabine phosphate 1.90 -52 105 Flurazepam monohydrochloride 1.90 -111 121 -113 5-Fluorocytosine 1.90 -169 175 Fluconazole 1.90 -108 117 -110 Sodium flurbiprofen dihydrate 9.0 -119 125 Transmitter frequency Compound offset O1, ppm Fluphenazine dihydrochloride -68 Fluoxetine HCl -68 Fludarabine phosphate -63 Flurazepam monohydrochloride -95 5-Fluorocytosine -123 Fluconazole -93 Sodium flurbiprofen dihydrate -98 Table 3: Analytical results for DMSO-[d.sub.6] soluble fluorinated pharmaceuticals.
Its Bioniche Pharma unit was given FDA approval of its ANDA for fludarabine phosphate
injection USR 25 mg/mL, packaged in 50 mg/2 mL single-dose vials.
M2 EQUITYBITES-October 5, 2010-Mylan Inc awarded approval for Fludarabine Phosphate Injection, USP(C)2010 M2 COMMUNICATIONS http://www.m2.com
Pharmaceutical company Mylan Inc (Nasdaq:MYL) announced on Monday the receipt of final approval from the US Food and Drug Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) for Fludarabine Phosphate Injection USP, 25 mg/mL, packaged in 50 mg/2 mL Single-dose Vials.
The product was determined to be bioequivalent and, therefore, therapeutically equivalent to Teva Parenteral's (part of Israeli Teva Pharmaceutical Industries Limited (TLV:TEVA)) Fludarabine Phosphate Injection USP, 25 mg/mL, a chemotherapy medication for B-cell chronic lymphocytic leukemia (CLL).
Fludarabine Phosphate Injection USP, 25 mg/mL had US sales of some USD15m (EUR11m) for the 12 months ending 30 June 2010, according to IMS Health.
Newer therapies using the purine analogs, specifically fludarabine phosphate
, have shown some promise.
The FDA has granted approval of its ANDA for fludarabine phosphate
injection, 25 mg/ml.
We describe a patient with B-CLL whose B cells expressed CD8, a predominantly T-cell marker also expressed in natural killer cells, and we propose that patients with this uncommon feature of B-CLL might have an increased sensitivity to fludarabine phosphate
, a substance recently often used to treat patients with CLL.
for Sicor Pharmaceuticals Fludara for