The FDA has approved Novo Nordisk’s new Diabetes drug Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in adults. Victoza, also known as Liraglutide, was launched in European markets in 2009 and has gained regulatory approval in Japan last week. Victoza belongs to a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help the pancreas make more insulin after eating a meal.

Endo Pharmaceuticals has announced that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information from Endo to address the agency’s concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism.

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Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd. said that FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years. The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies.

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.

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.

Drug developer Novartis received the FDA approval for its Valturna drug for the treatment of high blood pressure. The drug is a single-pill combination of valsartan and aliskiren. While Valsartan is the active ingredient in Novartis’ high blood pressure drug Diovan, aliskiren is the active ingredient in the company’s blood pressure drug Tekturna.