April FDA Pipeline

April 1, 2005

April FDA Pipeline

Approvable idesignations

Fast-track designations

Nonapprovable designations

A new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.

FDA approved a 40-mg powder for oral suspension formulation of omeprazole (Zegerid, Santarus/Otsuka). The new formulation is indicated for the reduction of risk of upper GI bleeding in critically ill patients and for the short-term treatment (4–8 wk) of active benign gastric ulcers.

FDA approved a new high-potency fluocinonide cream (Vanos, Medicis) for the once- or twice-daily treatment of plaque psoriasis.

The manufacturers of somatropin (rDNA origin) for injection (Tev-Tropin, Teva/Savient) have announced the launch of the growth hormone product for the treatment of children with short stature due to growth hormone deficiency.

FDA granted full approval for doxorubicin liposome injection (Doxil, Tibotec Therapeutics) in the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

A new aqueous solution formulation of oxaliplatin (Eloxatin, Sanofi-Aventis) was approved for the treatment of colorectal cancer.

FDA approved an intravenous immune globulin (Vaccinia Immune Globulin [VIGIV], Computer Sciences) to treat rare adverse reactions to smallpox vaccination.

FDA Actions in briefA new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.

FDA approved a 40-mg powder for oral suspension formulation of omeprazole (Zegerid, Santarus/Otsuka). The new formulation is indicated for the reduction of risk of upper GI bleeding in critically ill patients and for the short-term treatment (4-8 wk) of active benign gastric ulcers.

FDA approved a new high-potency fluocinonide cream (Vanos, Medicis) for the once- or twice-daily treatment of plaque psoriasis.

The manufacturers of somatropin (rDNA origin) for injection (Tev-Tropin, Teva/Savient) have announced the launch of the growth hormone product for the treatment of children with short stature due to growth hormone deficiency.

FDA granted full approval for doxorubicin liposome injection (Doxil, Tibotec Therapeutics) in the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

A new aqueous solution formulation of oxaliplatin (Eloxatin, Sanofi-Aventis) was approved for the treatment of colorectal cancer.

FDA approved an intravenous immune globulin (Vaccinia Immune Globulin [VIGIV], Computer Sciences) to treat rare adverse reactions to smallpox vaccination.