Sunday, December 6, 2009

New Drug Approvals

Here are some updates on drug research and technology from my reading-

Kalbitor approved for angioedema in 16 years and older :

On December 2, 2009, Dyax announced FDA’s approval of Kalbitor (Ecallantide) for the treatment of acute attacks of hereditary angioedema in patients 16 years and older.
HAE is a rare, genetic disorder characterized by severe, debilitating and often painful swelling, which can occur in the abdomen, face, hands, feet and airway. Kalbitor, a potent, selective and reversible plasma kallikrein.

FDA approved 10 mcg dose of Vagifem for the teatment of Atrophic vaginiitis due to menopause :

On December 2, 2009, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause - a condition experienced by up to 75 percent of postmenopausal women. This approval makes Vagifem 10 mcg the lowest local estrogen therapy (LET) dose commercially available in the U.S.
Sanofi- Aventis and FDA inform healthcare professionals of new warnings for Norpramin (Desipramine hydrochloride) :

On December 2, 2009, Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures.

Disclaimer : The above information has been cited from literature in public domain. This is for research purpose/ dissemination of knowledge only and should not be construed as medical advise

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