Barr Pharmaceuticals Inc. has received FDA approval for pramipexole dihydrochloride in 0.125mg, 0.25mg, 0.5mg, 1mg and 1.5mg strengths. This drug is the generic version of Boehringer Ingelheim Pharmaceuticals Inc.’s Mirapex tablets, used for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Barr is currently challenging a patent protecting Mirapex and has agreed not to launch its generic Mirapex until 90 days following the conclusion of the presentation of evidence in the district court trial, a favorable judgment is entered by the district court or July 14, whichever comes earlier.

Siemens AG has received FDA approval for its Versant 440 Molecular System for testing patients’ blood for the Hepatitis C virus. Versant 440 Molecular System, which represents the next generation in automated viral load testing, would be used with the Versant HCV RNA 3.0 assay for the management of patients infected with HCV and undergoing antiviral therapy. Versant 440 has already been approved in Europe, Africa and certain parts of Asia.

Abbott Laboratories has received FDA approval for its cholesterol treatment Simcor. The drug is a combination of a statin called simvastatin, which lowers “bad” cholesterol, and Abbott’s Niaspan, an extended-release version of niacin, which raises “good” cholesterol. The drug also lowers triglycerides, a type of blood fats. Abbott is conducting a study to determine Simcor’s effectiveness in preventing heart attacks and strokes. The results of this study are expected in 2011.

Ranbaxy Laboratories has received tentative approval from the FDA to market the generic version of AstraZeneca’s Nexium (esomeprazole magnesium) drug for the treatment of heartburn and gastroesophageal reflux disease (acid reflux). Generic Nexium has been approved in the 20mg and 40mg doses. The company has FTF (first to file) status on the drug, which potentially provides it with marketing exclusivity for 180 days after it receives final approval from the regulator.

MiddleBrook Pharmaceuticals has received FDA approval for its amoxicillin extended-release drug. The once-daily treatment for pharyngitis and/or tonsillitis (commonly referred as strep throat), to be marketed under the brand name Moxatag, has been approved for adults and children over 12 years of age. The market launch of the drug, which is the first product based on MiddleBrook’s time-release technology (called Pulsys), is expected in October or November 2008.

An FDA panel unanimously supported the approval of a long-acting, injectable form of Eli Lilly & Co.’s Zyprexa (olanzapine) drug for the treatment of schizophrenia patients. The panel of outside medical experts said the injectable formulation was “acceptably safe” for stable patients or those suffering from acute attacks. The rare risk of patients experiencing excessive sedation or even coma after the administration of the injection is acceptable, considering the effectiveness of the drug. All patients recovered fully and the use of the drug has been continued for most of them. Zyprexa is currently approved in the oral and short-acting injectable forms.

Merck & Co.’s Fosamax (alendronate sodium) now has competition. Teva Pharmaceutical Industries Ltd. has received FDA approval for a generic version of Fosamax for osteoporosis treatment. The generic has been approved in doses of 5 mg, 10 mg, 35 mg, 40 mg and 70 mg. The company has marketing exclusivity for 180 days and plans to commence shipment of the drug immediately.

Schering-Plough Corp. has received FDA approval for Asmanex Twisthaler, 110 micrograms, as a preventive therapy for asthma in kids between 4 and 11 years of age. This treatment is the first once-daily inhaler that can be used for treating children as young as 4. The FDA had approved Asmanex 220 micrograms on March 31, 2005, for preventing asthma flare-ups in patients who are 12 years or older.

Cangene Corp. has received FDA approval for Accretropin for the treatment of pediatric patients with short stature due to a genetic disorder, Turner Syndrome. Accretropin, an injectable human growth hormone (HGH), is part of a new class of drugs being developed using recombinant DNA technology. Apotex Group, Cangene’s largest shareholder, holds the marketing rights for the product.

Medtronic Inc. has received FDA approval for its CGMS iPro Recorder, a new physician use continuous glucose monitoring system. The CGMS iPro Recorder records the glucose pattern in a patient, who is advised to wear it for three days. The data is then reviewed by physicians to uncover glucose patterns in the patient and optimize therapy. The device is reimbursable by Medicare.