Status (Date)


Alza Corp.

Doxil (FDA-approved)

Doxorubicin HCl liposome injection

Refractory ovarian cancer

Oncologic Drugs Advisory Committee recommended approval of supplemental NDA (6/8); cleared for marketing (6/29)

Coulter Pharmaceutical Inc. and SmithKline Beecham plc (U.K.; NYSE:SBH)


Iodine I-131 tositumomab; murine monoclonal antibody against CD20 antigen on B cells, labeled with I-131

Relapsed or refractory, low-grade or transformed lowgrade B-cell non-Hodgkin's lymphoma

Submitted BLA (6/30)

Fujirebio Diagnostics Inc. (unit of Fujirebio Inc.; Japan)

CA19-9 RIA test kit

Detects CA19-9 antigen in blood serum using monoclonal antibodies

Diagnostic adjunct to radiological imaging techniques

Submitted product development protocol (6/9)

Ligand Pharmaceuticals Inc.

Targretin capsules

Bexarotene; synthetic retinoid analogue that selectively activates retinoid X receptors; oral formulation

Early-stage cutaneous T-cell lymphoma

Submitted NDA (6/23)

Sugen Inc.


Small-molecule angiogenesis inhibitor that blocks the signaling pathway of the vascular endothelial growth factor receptor

Colorectal and non-small-cell lung cancer

FDA cleared Phase III trial design (6/4)

U.S. Bioscience and Alza Corp.


Amifostine; selective cytoprotective agent

Moderate to severe post-operative, radiation-induced xerostomia in patients undergoing radiation treatment for head and neck cancer

Oncologic Drugs Advisory Committee recommended approval(6/9); cleared for marketing (6/24)


Cypros Pharmaceutical Corp.


Small molecule; acts during and after ischemia by maintaining cellular ATP levels or accelerating their restoration

Severe brain injury

Granted orphan drug status (6/30)


Gilead Sciences Inc.


Adefovir dipivoxil; reverse transcriptase inhibitor (oral)

HIV-infected patients with disease progression despite prior reverse transcriptase inhibitor therapy

Submitted NDA (6/29)

ID Biomedical Corp. (Canada)


Group A streptococcus (GAS) vaccine; subunit vaccine made from recombinantly produced terminal fragments of the surface M protein

Preventive vaccine against group A streptococcus infection

IND cleared (6/9)

Xoma Ltd.


Modified recombinant fragment of bactericidal/permeability-increasingprotein

Treatment of otitis media with effusion

Results of the Netherlands trial presented at the 7th International Symposium on Recent Advances in Otitis Media in Ft. Lauderdale, Fla. (6/2)


Alkermes Inc. and Genentech Inc.

Nutropin Depot

Sustained release formulation of Genentech's recombinant growth hormone based on Alkermes' ProLease injectable delivery system (administered once or twice a month)

Growth hormone deficiency in children

Submitted NDA (6/28)

Alza Corp.

Ditropan XL (FDA-approved)

Oxybutynin chloride extended-release tablets (via OROS osmotic drug-delivery technology); tablet formulation

Overactive bladder

Agency cleared 15 mg tablets for marketing (alongside previously approved 5 mg and 10 mg formulations) (6/24)

DUSA Pharmaceuticals Inc. (Canada; NASDAQ:DUSA)


Photodynamic therapy; 20% solution of amino-levulinic acid HCl (topical)

Multiple actinic keratoses of the face and scalp

Received approvable letter (6/29)

SangStat Medical Corp.


Generic azathioprine; immuno-suppressant that inhibitis development of T-cells by interfering with the differentiation and proliferation of activated lymphocytes

Adjunct therapy for prevention of organ transplant rejection

Abbreviated NDA filed (6/14)