Dey Pharma, L.P., has launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use. Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting. If you have Parkinson’s disease, your symptoms may temporarily get worse.

Salix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.

Theravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

Unichem Lab has received Abbreviated New Drug Abbreviation (ANDA) approval from the US FDA for clonidine hydrochloride tablets. Clonidine Hydrochloride is a low dose potent and popular molecule in the antihypertensive category. Clonidine hydrochloride tablets USP 0.1mg, 0.2mg and 0.3mg are therapeutically equivalent to Catapres tablets USP 0.1mg, 0.2mg and 0.3mg from Boehringer Ingelheim. Clonidine hydrochloride formulations have annual sales of roughly $334 million in the US.

Watson Pharmaceuticals has received FDA approval for a generic version of the high blood pressure and angina drug Toprol XL. Watson Pharma expects to starts shipping the metoprolol drug immediately. The drug would be available in 25 mg and 50 mg extended-release tablets. According to Watson Pharma, the US sales of Toprol XL and generic equivalents totaled $628 million for the year ended June 30, 2009.

Hospira has obtained approval for its anti-infective Azithromycin injection from the FDA. Azithromycin is a generic variant of Pfizer’s Zithromax and is ADD-Vantage system compatible. ADD-Vantage is an advanced drug delivery system that does not need a needle and syringe to mix the drug with the solution. This lowers the risk of accidental needle pricks, improves workflow and prevents waste due to stability and shelf-life elements.

BioDelivery Sciences International Inc has received approval from the FDA to market Onsolis to treat breakthrough pain in certain cancer patients. The drug is expected to be available in the fourth quarter of 2009 and will be commercialized in the US by Meda Pharmaceuticals. Onsolis delivers the potent opioid fentanyl via a film that sticks to the inside of a patient’s cheek.

Glenmark Generics Inc and partner InvaGen has got the Abbreviated New Drug Application (ANDA) approval from the FDA for Fosinopril Sodium and Hydrochlorothiazide tablet to be used for the treatment of hypertension. Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths. While Glenmark would exclusively market and distribute the product in the US, InvaGen would manufacture and supply the drug.

The FDA has asked the makers of Singulair, Accolate, Zyflo and Zyflo CR drugs to include the precaution regarding the reported changes in behavior and mood on their label. All these drugs are used to treat asthma and are leukotriene inhibitors, which affect the leukotriene pathway involved in the body’s response to inflammatory stimuli.

A new study published in The Journal of the American Medical Association shows that deep brain stimulation may show better improvements in disability and quality of life, as compared to other state-of-the-art treatments for patients with advanced Parkinson’s disease. However, there were also more serious side effects in patients who got deep brain stimulation. Deep brain stimulation requires the surgical implantation of electrodes and a device in the brain in order to electrically stimulate certain brain regions.