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Gemcitabine (Gemspera (1400 mg)) is a nucleoside analog used in chemotherapy for treating certain types of cancer (like lung cancer, pancreatic cancer, breast cancer, ovarian cancer). The ...
In January 2011, Teva Pharmaceuticals USA, Inc. received approval and APP Pharmaceuticals launched Gemcitabine HCI for Injection in the 200 mg and 1g dosage forms as part of a commercialization ...
approval of gemcitabine injection, a solution form of the drug. The solution presentations include 200 mg, 1 gm and 2 gm with a concentration of 38 mg/ml. The oncology medication had U.S. sales of ...
Under the terms of the agreement APP has been granted a license to market Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials during the 180 day Hatch Waxman exclusivity period.
Sixty-four patients (34 men, 30 women; mean and standard deviation [SD] age, 63 ± 14 years) were treated with gemcitabine (mean dose, 984 ± 158 mg/m 2). These patients ... an 8-day period after ...
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