New FDA Orphan Drugs

New FDA Orphan Drugs: CDX-110, ATryn, ISIS 333611 The FDA has granted orphan drug designation to CDX-110 for the treatment of glioblastoma multiforme, ATryn for the treatment of hereditary antithrombin deficiency, and ISIS 333611 for the treatment of amyotrophic lateral sclerosis.
News, December 21, 2007
New FDA Orphan Drugs: KNS-760704, Colchicine, Panobinostat The FDA has granted orphan drug designation to KNS-760704 for the treatment of amyotrophic lateral sclerosis, colchicine for the treatment of familial Mediterranean fever and Behcet's Syndrome, and panobinostat for the topical treatment of cutaneous T-cell lymphoma.
News, October 19, 2007
New FDA Orphan Drugs: MB07133, VitiGam, ALS-357 The FDA has granted orphan drug designation to MB07133 for the treatment of liver cancer, VitiGam for the treatment of stage IIB to stage IV metastatic melanoma, and ALS-357 for the topical treatment of metastatic melanoma.
News, October 05, 2007
New FDA Orphan Drugs: IPI-504, Pafuramidine, Preos The FDA has granted orphan drug designation for IPI-504 for the treatment of gastrointestinal stromal tumors, pafuramidine for the treatment of African sleeping sickness, and Preos for the treatment of hypoparathyroidism.
News, September 21, 2007
New FDA Orphan Drugs The FDA has granted orphan drug designation for 5(S)-(2'-hydroxyethoxy)-20(S)-camptothecin for the treatment of osteosarcoma, 5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one (Bio 300) for the treatment of acute radiation syndrome, and autologous cultured endothelial cells on a donor human corneal disk for the treatment of Fuch's dystrophy, bullous keratopathy, and pseudophakic bullous keratopathy.
News, July 27, 2007
New FDA Orphan Drugs The FDA has granted orphan drug designation for leukocyte interleukin as neoadjuvant therapy for patients with squamous cell carcinoma of the head and neck, pafuramidine maleate for the prevention of malaria, and plevitrexed for the treatment of gastric cancer.
News, June 15, 2007
New FDA Orphan Drugs: AMT 011, Axitinib, Gene Tx for Juvenile Retinoschisis The FDA has granted orphan drug designation for AMT 011 for the treatment of lipoprotein lipase deficiency, axitinib for the treatment of pancreatic cancer, and adeno-associated viral vector expressing human retinoschisin-1 gene for the treatment of X-linked juvenile retinoschisis.
News, June 08, 2007
New FDA Orphan Drugs: Gestiva, Onconase, Aerosolized Ciprofloxacin The FDA has approved orphan drug status for a long-acting injectable form of a naturally occurring progesterone (Gestiva), ranpirnase (Onconase), and an inhaled liposomal formulation of ciprofloxacin.
News, February 26, 2007
New FDA Orphan Drugs: Droxidopa, LX201, Marqibo The FDA has granted orphan drug status to L-threo-dihydroxyphenylserine (Droxidopa), a cyclosporine A-eluting ocular implant (LX201), and vincristine sulfate liposomes injection (Marqibo).
News, January 30, 2007
New FDA Orphan Drugs: SIGA-246, Ampydin, TTI-1612 The FDA has granted orphan drug status for a proteinase inhibitor (SIGA-246); an immediate release, oral version of 4-aminopyridine (Ampydin); and a small, orally available recombinant protein (TTI-1612).
News, January 09, 2007
New FDA Orphan Drugs: CellCept, ISIS 301012, 5-HMF The FDA has approved orphan drug status for mycophenolate mofetil (CellCept), a second-generation antisense drug (ISIS 301012), and a 5-membered heterocyclic anti-sickling compound (5-HMF).
News, June 09, 2006
New FDA Orphan Drugs: Zadaxin and Nexavar The FDA has approved orphan drug indications for thymalfasin injection (Zadaxin) and sorafenib tosylate tablets (Nexavar).
News, May 02, 2006
New FDA Orphan Drugs: Lestaurtinib, TRX4, and EPI-A0001 The FDA has approved orphan drug status for CEP-701 (lestaurtinib), ChAglyCD3 (TRX4), and EPI-A0001.
News, April 11, 2006
New FDA Orphan Drugs: Ceflatonin, Valortim, TQ-1018 The FDA has approved orphan drug status for homoharringtonine (Ceflatonin), MDX-1303 (Valortim), and a high-concentration topical capsaicin product (TQ-1018).
News, March 31, 2006
New FDA Orphan Drugs: Amphotericin B Inhalation Powder, TRX4, AT2101 The FDA has approved orphan drug status for an inhalation powder formulation of amphotericin B, an immunologic therapy for type 1 diabetes (TRX4), and an orally active drug for Gaucher disease (AT2101).
News, March 02, 2006
New FDA Orphan Drugs: iPlex, Cethrin, Brivaracetam The FDA has approved orphan drug indications for mecasermin rinfabate [rDNA origin] subcutaneous injection (iPlex), BA-210 (Cethrin), and UCB-34714 (Brivaracetam).
News, December 13, 2005
New FDA Orphan Drugs: Zactima, Surfaxin, IL-21 The FDA has approved orphan drug status for ZD6474 (Zactima), lucinactant (Surfaxin), and interleukin 21 (IL-21).
News, November 08, 2005
New FDA Orphan Drugs: Amplimexon, AP23573, TQ-1017 The FDA has approved orphan drug status for imexon injection (Amplimexon), a non-prodrug rapamycin analog (AP23573), and an abuse-deterrent once-daily formulation of tramadol HCl (TQ-1017).
News, September 06, 2005
New FDA Orphan Drugs: Bronchitol, Prestara, GTI-2040 The FDA has approved expanded orphan drug indications for mannitol dry inhalation powder (Bronchitol) and prasterone (Prestara) and a new orphan drug indication for an antisense drug (GTI-2040).
News, July 27, 2005
New FDA Orphan Drugs: CTCE-9908, PEAC, Arimoclomol The FDA has approved orphan drug status for a cytostatic drug (CTCE-9908), an orally administered galenic version of valproic acid (PEAC minitablets), and a small molecule drug (arimoclomol).
News, July 20, 2005

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