The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. The traditional approval is based on 48-week data from two Phase 3 studies known as DUET-1 and DUET-2.

Organon has announced the launch in India of its vaginal ring that contains the same hormones found in the oral pill, but is to be self-inserted only once-a-month for contraceptive action. The ring was approved by the US Food and Drug Administration in 2001. The Central Drugs Control Standards Organisation (CDSCO) in New Delhi approved the contraceptive ring for marketing in India in 2005.

CSL Behring has announced that the FDA has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE).  Berinert is the first therapy approved for this indication in the U.S. The approval is based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy and safety of C1-inhibitor concentrate.

Angiotech Pharmaceuticals, Inc. has launched the Tan EndoGlide(TM) Endothelium Insertion System in the United States. Angiotech holds exclusive U.S. distribution rights to market and distribute the Tan EndoGlide Endothelium Insertion System. The Tan EndoGlide is a device used to facilitate insertion of a donor endothelium during Endothelial Keratoplasty. The device is used by Ophthalmologists adapting to newer techniques to replace diseased corneal endothelium.

The National University of Singapore researchers have discovered a new way to take an electrocardiogram (ECG) of the heart – with a T-shirt. The garment, which has the technology sewn into it, will help doctors monitor those who have recently undergone heart surgery and patients with irregular heartbeats. The team is also looking at modifying the T-shirt ECG monitoring system to help asthma patients.

Generex Biotechnology Corporation has been granted price approval by the US Food and Drug Administration approval for the use of Generex Oral-lyn(TM) under the FDA’s Treatment Investigational New Drug (IND) program. Generex was previously granted the FDA approval for the use of Generex Oral-lyn(TM) in patients with Type 1 or Type 2 diabetes mellitus under the FDA’s “Treatment IND” rules.

The prescription drug Avandia (rosiglitazone), marketed as a treatment for Type II diabetes, causes an increase in liver problems, heart problems and bone density problems resulting in fractures. It has been linked to cases of death due to liver failure and heart failure. Patients who have a history of certain medical conditions, such as heart disease, heart attack, high blood pressure, smoking and stroke, and those taking medications including diuretics, steroids, seizure medication and thyroid medication are more prone to experiencing serious side effects while taking Avandia.

Daiichi Sankyo Inc’s supplemental new drug application (sNDA) for Welchol has ben approved by the FDA. Welchol is to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol in boys and postmenarchal girls, aged between 10 and 17 years suffering from heterozygous familial hypercholesterolemia. The drug can be used alone or in combination with a statin after failing an adequate trial of diet therapy.

Wockhardt received the tentative approval from the FDA for marketing Tamsulosin Hydrochloride capsules for the treatment of prostate related problems. The drug will be available in 0.4 mg strengths. Tamsulosin is the generic name for the brand Flomax, marketed by the drug firm Boehringer Ingelheim, and the patent for the drug is scheduled to expire on 2010. Wockhardt will launch the drug after the patent expiry date. According to research firm IMS, the total market for Tamsulosin capsules in the US is about $1.6 billion per annum.

The FDA has approved Novartis Pharmaceuticals’ Valturna (aliskiren and valsartan) tablets, the first and only medicine to target two key points within the renin system. Also known as the renin angiotensin aldosterone system (RAAS), it is an important regulator of blood pressure. Valturna is to be used for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.