Pittsburgh – Mylan Inc. recently had received FDA approval for the generic hypertension drug, Teveten.

Teveten, or eprosartan mesylate, is marketed by Abbott Laboratories Inc. Mylan said Teveten’s U.S. sales totaled $4.9 million over the year ended Sept. 30.

Mylan said it is now shipping generic Teveten in strengths of 400 milligrams and 600 milligrams. It will have six months of marketing exclusivity.

For more information about Mylan, please visit www.mylan.com. To buy Teveten online, please check the product details here.

July 01, 2011 /FDA.gov/NewsEvents/ — FDA News Release. The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

COPD is a serious lung disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, and is the fourth leading cause of death in the United States, according to the Centers for Disease Control and Prevention.
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FDA Approved

On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.

Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Epilepsy is a brain disorder in which there is abnormal or excessive activity of nerve cells in the brain. Partial seizures affect only a limited or localized area of the brain, but can spread to other parts of the brain. Seizures cause a wide range of symptoms, including repetitive limb movements (spasms), unusual behavior, and generalized convulsions with loss of consciousness.
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Horizon Pharma, Inc., a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved Duexis (ibuprofen/famotidine), a novel tablet formulation containing a fixed-dose combination of ibuprofen (800 mg) and famotidine (26.6 mg). The FDA approval was supported by data from the pivotal REDUCE-1 and REDUCE-2 studies, which showed patients taking Duexis experienced significantly fewer upper gastrointestinal ulcers compared to patients receiving ibuprofen alone.

“We look forward to providing Duexis to the many patients suffering from osteoarthritis and rheumatoid arthritis, as it provides a new treatment option for those who may be at risk for upper gastrointestinal ulcers stemming from chronic NSAID use,” said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. “The approval of DUEXIS is a transformative event for Horizon Pharma, representing our first U.S. approval. We would like to thank the patients and clinical investigators who participated in the pivotal REDUCE-1 and REDUCE-2 trials.”

Duexis was studied in more than 1,500 patients with mild-to-moderate pain or arthritis.

Click >HERE< for information on Horizon Pharma Announces FDA Approval of Duexis from MarketWire – Apr 25, 2011.

The FDA has approved a Livalo, a new cholesterol-lowering statin drug.

Known by the generic name of pitavastatin, Livalo has been used in Japan since 2003. It’s also sold in Korea and Thailand. Livalo is made by the multinational Japanese firm Kowa Company Ltd., which now has facilities in the U.S.

Livalo will join the growing list of statins approved for U.S. sale:

• Crestor (rosuvastatin)

• Lescol (fluvastatin)

• Lipitor (atorvastatin)

• Mevacor (lovastatin)

• Pravachol (pravastatin)

• Zocor (simvastatin)

Statins are approved for patients unable to sufficiently lower their cholesterol levels by diet and exercise. All of the drugs work by inhibiting HMG Co-A reductase, a liver enzyme that makes cholesterol.

Click >HERE< for information on FDA Approves New Cholesterol-Lowering Drug Livalo from WebMD.