Shire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).

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.

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.

Covidien announced the launch of Permacol™ Biologic Implant, a biologic mesh for hernia repair. The implant joins Covidien’s line of products as a result of acquisition of Tissue Science Laboratories by the company. It will be available in the American and  European markets in 2009. Containing improved porcine collagen, Permacol™ Biologic Implant brings together the clinical benefits of a biologic and a synthetic’s intra-operative efficiency. The hydrated and ready-to-use product can be cut or shaped as required, providing a suitable soft tissue repair.

The U.S. Food and Drug Administration has classified Physio-Control, Inc.’s medical device recall of 249 fully automatic LIFEPAK CR Plus automated external defibrillators (AEDs) as a Class I action. Some of these devices manufactured between May 2004 and April 2007 are configured incorrectly. The shock button can not be located as it is covered in the fully automated device. This may lead to a delay in delivery of therapy as a patient complained. Physio-Control has notified replacement devices at no charge to all the affected customers.

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.

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.

Global healthcare provider Roche acquired Ventana Medical Systems in a merger on January 22. Both companies’ boards approved the merger agreement, which included a premium of 4.9% to Ventana’s shareholders. Ventana employees will also be able to continue working for the company at the existing location in Arizona.

Roche expects to gain growth in companion diagnostics as well as advanced and primary staining from its acquisition. It is currently the world’s biggest biotech company, and global leader of in-vitro diagnostics, cancer pharmaceuticals and transplantation, and virology.