FDA Approval Activities for this Drug…

Hycamtin (topotecan hydrochloride) Injection, SmithKline Beecham NDA 20-671/S-012 5/9/03 7/9/03 7/9/03 Hycamtin (topotecan hydrochloride) Injection, 4 mg., SmithKline Beecham NDA 20-671/S-011 3/11/03 4/1/03 Hycamtin (topotecan hydrochloride) for Injection, 4 mg., Pediatric Study SmithKline Beecham NDA 20-671/S-010 2/26/03 Hycamtin (topotecan hydrochloride) for Injection, 4 mg., SmithKline Beecham NDA 20-671/S-009 3/6/02 3/12/02 Hycamtin (topotecan hydrochloride) for Injection, SmithKline Beecham NDA 20-671/S-004 11/30/98 1/12/99 1/12/99 3/13/00 Hycamtin Indication: This supplemental new drug application provides for the useof Hycamtin in the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy.

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