FDA December 2013 Products Receiving Orphan Designation

Orphan Druganaut Blog

Please note: Updated 01/02/14 with 12/31/13 FDA Updates.

The chart below identifies FDA December 2013 Products Receiving Orphan Designation as of 01/02/14 in ascending “Designation Date” order.

Some Observations

•   21 products receive orphan designation in December 2013 (as of 01/02/14)

•   2 products receive orphan designation for Multiple Myeloma

•   Canakinumab receives orphan designation for 2 indications

•   20 % of the orphan designations are for an oncology indication.

FDA December 2013 Products Receiving Orphan Designation


Generic NameDesignation DateOrphan Designation


                                                                      Canakinumab12-05-2013Familial Mediterranean Fever


     Canakinumab12-05-2013Hyperimmunoglobulinemia D


Periodic Fever Syndrome


     Sotatercept12-05-2013Beta-Thalassemia Intermedia

and Major


     O2-(2,4-dinitrophenyl)   1-[(4-ethoxycarbonyl)piperazin-1yl]diazen-1-ium-1,2-diolate12-13-2013Multiple Myeloma


     Marizomib   12-13-2013Multiple Myeloma



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How to Stay Motivated

Lead Today

The pain of discipline is greater than the pain of failure. That simple fact leads to more failure than any other single factor. When we lack the discipline required for success we also lack the ability to “push-on” when we face the struggles associated with long-lasting success. There are struggles within every successful endeavor and within every successful endeavor someone found the motivation to continue the way forward.

Average people need someone to motivate them. Successful people find a way to motivate themselves and ask for help when they can’t. Here are just a few of the methods they use to get going when the going gets tough:

They re-dream the dream. Before they quit they remember why they started, they remember what’s in it for them if they can keep going. They see the end of the rainbow and reach for it again. It is that “reach” that…

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Drug spotlight- Zafirlukast

New Drug Approvals



cyclopentyl 3-{2-methoxy-4-[(o-tolylsulfonyl)carbamoyl]benzyl}-1-methyl-1H-indol-5-ylcarbamate107753-78-6

Matassa, V.G. et al, J. Med. Chem., v. 33, 1781 (1990);

U. S. Patent No. 4,859,692;

U. S. Patent No. 5,993,859;


Zafirlukast is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma, often used in conjunction with an inhaled steroid and/or long-acting bronchodilator. It is available as a tablet and is usually dosed twice daily. Another leukotriene receptor antagonist is montelukast (Singulair), taken once daily. Zileuton (Zyflo), also used in the treatment of asthma via its inhibition of 5-lipoxygenase, is taken four times per day.

Zafirlukast blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors, thus reducing constriction of the airways, build-up of mucus in the lungs andinflammation of the breathing passages.

Zafirlukast is marketed by Astra Zeneca with the brand names AccolateAccoleit, and Vanticon. It was the…

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