Company* | Product | Description | Indication | Status (Date) |
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CANCER | ||||
EntreMed | ENMD 0995 | A new derivative of | Multiple myeloma | FDA granted orphan drug status to ENMD 0995 (11/7) |
Guilford Pharmaceuticals Inc. (GLFD) | Gliadel Wafer | Biodegradable polyanhydride polymer wafer implant containing carmustine | High-grade | Company submitted to the FDA an amendment to its supplemental NDA for Gliadel Wafer seeking approval for use during initial surgery for high-grade malignant glioma (11/1) |
MGI Pharma | Palonosetron | Differentiated 5-HT3 receptor antagonist | Chemotherapy- induced nausea and vomiting | FDA accepted the NDA for filing (11/26) |
SuperGen Inc. | Mitozytrex | Version of generic | Disseminated adenocarcinoma | FDA approved the product for marketing (11/15) |
SuperGen Inc. | Orathecin | Rubitecan; oral | Pancreatic | FDA designated Orathecin oral as a fast-track product to treat patients with locally advanced or metastatic pancreatic cancer that is resistant or refractory to chemotherapies (11/11) |
INFECTION |
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Demegen Inc. | P113D | Peptide derived | Cystic fibrosis | FDA granted orphan drug status (11/5) |
Nabi Biophar- | Nabi-HB Intravenous (FDA-approved) | Hepatitis B immune | Hepatitis B | Company submitted a BLA (11/26) |
Triangle Pharmaceuticals Inc. (VIRS) | Coviracil | Emtricitabine; a nucleoside reverse transcriptase inhibitor | HIV | FDA accepted for review the NDA (11/4) |
MISCELLANEOUS | ||||
NexMed Inc. | Alprox-TD | Cream treatment | Erectile | FDA advised the company to stop the ongoing open-label study of Alprox-TD cream until resolving certain issues surrounding NexMed's 26-week transgenic mouse study (11/14) |
Novavax Inc. | Estrasorb | An estradiol topical | To reduce | FDA accepted for review the NDA, which was resubmitted on Sept. 9 (11/12) |
Repligen Corp. | SecreFlo (FDA- | A synthetic porcine | To aid in the location and cannulation of the pancreatic ducts in patients undergoing ERCP | FDA approved a supplemental NDA for SecreFlo (11/4) |
Zonagen Inc. | Vasomax | Immediate-release oral formulation of phentolamine mesylate, a short-term alpha-adrenergic receptor blocker that stimulates smooth muscle relaxation and causes vasodilation | Erectile | FDA is requiring an additional two-year rodent study in order to lift the clinical hold on Vasomax; the company does not anticipate doing another study (11/19) |
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Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
BLA = Biologics License Application; NDA = New Drug Application | ||||
