New and Generic Drug Approvals for September 6, 2011

Drugs Have to Seek FDA Approval - Wurfel
Drugs Have to Seek FDA Approval - Wurfel
Five new labeling revisions and one new drug were approved on Sept. 6, 2011 by the FDA.

According to the Food and Drug Administration, there were seven drug approvals done for the sixth of September, 2011. These include five labeling revisions and one drug approval.

Brovana

The inhalation solution arformoterol tartrate, also known as Brovana, was granted a labeling revision. The Sunovion Pharmaceutical Inc drug is used “to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema)”, according to the National Institute of Health.

Cymbalta

The delayed-release capsule duloxetine hydrochloride, also known as Cymbalta, was granted a labeling revision. The Eli Lilly and Company drug is used to treat anxiety and depression. Other uses are for diabetic neuropathy and for chronic pain.

Carbatrol

The extended-release capsule carbamazepine, also known as Carbatrol, was granted a labeling revision. The Shire Incorporated drug is for seizure control. It is also used for trigeminal neuralgia which causes facial nerve pain. There are some who use it for episodes of mania.

Fosrenol

The chewable tablet lanthanum carbonate, also known as Fosrenol, was granted a labeling revision. The Shire Development Incorporated drug is for reducing phosphate levels in the blood in kidney disease patients. It is a phosphate binder that prevents absorption of food phosphates in the stomach.

Multaq

The tablet dronedarone hydrochloride, also known as Multaq, was granted a labeling revision. The Sanofi-aventis LLC drug treats atrial fibrillation which is a fast and irregular heartbeat disorder. It is also for atrial flutter which is a fast but regular heartbeat disorder.

Metozolv ODT

The orally disintegrating tablet metoclopramide, also known as Metozolv ODT, was granted a labeling revision. The Salix Pharmaceuticals drug is “for acute and recurrent diabetic gastroparesis and short-term treatment for refractory GERD” according to the drug’s website.

Haloperidol

This injection from the Sagent Pharmaceuticals company was granted approval. It is given for psychotic disorders that “cause difficulty telling the difference between things or ideas that are real and things or ideas that are not real” according to the National Institute of Health. Typically, it is for schizophrenia. It is classified as an antipsychotic in the butyrophenone class. This drug will launch to a national audience in the fourth quarter of 2011.

Drugs can go through many different types of approvals. These are the latest that have come through the Food and Drug Administration for use in the United States.

Source: FDA

http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm

Tina at a Booksigning , (C)Tina Samuels

Tina Samuels - Tina Samuels specializes in health, animal, and gardening articles. She authored "A Georgia Native Plant Guide".

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