Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

The FDA has approved Onglyza, a once-daily treatment for type 2 diabetes to be taken in combination with diet and exercise. Onglyza, manufactured by Bristol-Myers Squibb, was tested in diabetes patients at relatively low risk of heart disease. The FDA approval requires Bristol-Myers Squibb to conduct a postmarketing study to evaluate the drug’s heart safety in higher-risk patients.

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.

Amag Pharmaceuticals has received clearance from the FDA to sell its iron deficiency drug in the US market. The intravenous drug, feromoxytol, will be marketed under the brand name Feraheme for adult patients suffering from anemia with chronic kidney disease. The company expects the drug tobe available for commercial use during the second half of July.

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.

Beckman Coulter, Inc. ushers in a new era of cellular analysis with the release of the UniCel(R) DxH 800 Coulter(R) Cellular Analysis System. Capturing 29 individual measurements per cell analyzed, the system provides improved sensitivity and specificity, which means more reliable assessment of abnormal cell populations. Laboratories equipped with the system will be able to respond more quickly and accurately to physician demands, improving patient health and reducing the cost of care. The system’s all new physical design minimizes moving parts, increasing instrument reliability and technologist efficiency.

Boston Scientific Corporation has announced that it has received approval from the U.S. Food and Drug Administration to market its Apex™ PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter. It has been developed specifically to address physicians’ needs in treating the most challenging atherosclerotic lesions. The Apex Catheter is available for distribution in both Monorail® and Over-The-Wire (OTW) catheter platforms. It represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment™ inner shaft for improved pushability and flexibility.

The U.S. Food and Drug Administration has granted the marketing approval to Salix Pharmaceuticals’ APRISO (mesalamine) extended-release capsules 0.375 g. A locally-acting aminosalicylate, APRISO has been approved for the remission of ulcerative colitis (UC) in adults. APRISO is the only mesalamine product to receive an FDA approval as once-daily drug for the maintenance of remission of UC. Also, it is the first ever 5-ASA with Intellicor(TM) extended release delivery technology. The product will be available to physicians by early 2009.

The U.S. Food and Drug Administration has expanded the indication for Hospira, Inc.’s Precedex(R) for use in non-intubated patients needing sedation before or during surgical procedures. Anesthesiologists, now, can administer Precedex safely for a growing number of out-patient applications like ophthalmic and orthopedic procedures.The broader indication is based on the results of two clinical trials involving 431 patients.