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.

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for  patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

Teva Pharmaceutical’s ProAir HFA, an albuterol sulfate inhalation solution has received an expanded indication from the U.S. Food and Drug Administration for treating bronchospasm in children suffering with reversible obstructive airway disease. Previously approved for patients above 12 years of age, ProAir HFA is now recommended for patients older than 4 years. The indication was expandedc on the basis of a 3-week long study which concluded that 2 inhalations of the solution 4 times a day treated the symptoms significantly.

A new oral medication for type two diabetes is now available in Australia. The drug, Januvia, is designed to manage the nation’s fastest growing chronic disease in a better way, with which millions of Australians are suffering. Given a single dose a day, “Januvia boosts the effect of a natural body process called the incretin system”, Sydney’s Royal North Shore Hospital, Greg Fulcher said in a statement. Incretins are intestinal hormones that are released after the intake of food. They are essential for regulating blood glucose. Type two diabetes patients have impaired incretins. The drug, the first ever oral medication for the purpose, is a Merck & Co product.

Actavis Group’s U.S. division, Actavis Totowa LLC, has recalled all lots of heart failure treatment Digitek (digoxin tablets). The company announced the Class I nationwide recall for Digitek after the possible commercial release of tablets with twice the approved level of the active ingredient, posing a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.

GlaxoSmithKline PLC has launched a new treatment for Parkinson’s disease (PD) in the U.K. ReQuip XL® (ropinirole prolonged-release tablets) is the U.K.’s first and only once-daily non-ergot oral dopamine agonist available for the treatment of PD1, providing continuous delivery of ropinirole from a single daily dose. Ropinirole prolonged-release is approved for the treatment of idiopathic Parkinson’s disease (Monotherapy and Adjunct Therapy) in patients already taking ropinirole immediate release tablets and in whom adequate symptomatic control has been established.

 Mylan Pharmaceuticals has received final approval from the FDA for its ANDA for felodipine extended-release tablets as a treatment for hypertension. Felodipine is the generic version of AstraZeneca’s Plendil. Mylan aims to start shipping generic Plendil immediately.

InterMune Inc. announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF)who have completed one of the two concurrent Phase III CAPACITY trials of pirfenidone in IPF. Pirfenidone, which has been granted orphan drug designation in the both the U.S. and Europe, has depicted positive impact on lung function and disease progression in patients suffering from the fatal IPF disease.

Teva Pharmaceutical Industries has received FDA approval for the Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer’s chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection. Camptosar’s patent expired last month and the drug had annual sales of about $556 million in the U.S. in the twelve months ended December 31, 2007. The other companies that have received approval to launch the generic version of Pfizer’s chemotherapy agent are Actavis and APP Pharmaceuticals.