Company* (Country; Symbol)

Product

Description

Indication

Status (Date)

CANCER

Callisto Pharmaceuticals Inc. (OTC BB:CLSP)

Atiprimod

Drug designed to inhibit VEGF and interleukin-6

Multiple myeloma

The FDA granted orphan status to the drug, which is being taken into a Phase I/II trial (1/6)

OSI Pharmaceuticals Inc. (OSIP) and GenentechInc. (NYSE:DNA)

Tarceva (erlotinib)

Small-molecule HER1/EGFR inhibitor

Incurable non- small-cell lung cancer

Companies and Roche Holdings Inc. began rolling NDA submission available under FDA fast-track provisions (1/21)

SuperGen Inc. (SUPG)

Orathecin

Rubitecan; oral topois- omerase-I inhibitor in capsule formulation

Refractory pancreatic cancer

SuperGen completed its rolling NDA submission with the FDA; the product has fast-track desig- nation in this indication (1/27)

CENTRAL NERVOUS SYSTEM

Cephalon Inc. (CEPH)

Provigil (FDA-approved)

Modafinil tablets

Excessive sleepiness

The FDA approved added labeling for the product to include excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder (1/26)

Pozen Inc. (POZN)

MT 100

Combination of metoclopramide and naproxen

Migraine

Pozen submitted data from a rat carcinogenicity study to the FDA, the final piece of an NDA filed in July (1/28)

INFECTION

Vicuron Pharmaceuticals Inc. (MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Esophageal candidiasis

The FDA extended its review per- iod of the NDA by 90 days, to May 25; the agency asked for additional pharmacokinetic data (1/22)

MISCELLANEOUS

Genentech Inc. (NYSE:DNA)

Nutropin (FDA-approved)

Somatropin for injection

Idiopathic short stature

Genenetech filed a supplemental new drug application seeking labeling to include long-term treatment in that indication (1/14)

Inspire Pharmaceuticals Inc. (ISPH)

Diquafosol tetrasodium

Ophthalmic solution

Dry eye

The FDA said another trial was needed to confirm efficacy; the agency issued an approval letter in December (1/30)

Transkaryotic Therapies Inc. (TKTX)

Replagal

Fully human alpha- galactosidase A protein

Fabry's disease

TKT said it will stop seeking approval of the product, after FDA said a trial comparing it to the orphan drug Fabrazyme would be needed to show superiority (1/12)

Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

NDA = New drug application.

NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board.