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

Num

Generic NameDesignation DateOrphan Designation

1

                                                                      Canakinumab12-05-2013Familial Mediterranean Fever

2

     Canakinumab12-05-2013Hyperimmunoglobulinemia D

and

Periodic Fever Syndrome

3

     Sotatercept12-05-2013Beta-Thalassemia Intermedia

and Major

4

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

5

     Marizomib   12-13-2013Multiple Myeloma

6

     Human…

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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

Zafirlukast.svg

ZAFIRLIKAST 

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;

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020547s031lbl.pdf

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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