The U.S. Food and Drug Administration has approved Sanofi-aventis’ Apidra (insulin glulisine injection) to recover glycemic control in children above the age of 4 years suffering from diabetes mellitus. The approval for pediatric use of the injection is based upon FDA’s review of a 6 month long phase III study involving 572 children with type 1 diabetes. Apidra(R), having a rapid onset and shorter period of action, should normally be used along with a basal insulin with a longer duration of action. The product can also be applied in insulin infusion pump treatment for controlling blood sugar.

The U.S. Food and Drug Administration has approved Duramed Pharmaceuticals’ LoSEASONIQUE(R) extended-cycle oral contraceptive. The product is the first lower-dose, extended-cycle oral contraceptive approved for the prevention of pregnancy. The LoSEASONIQUE(R) regimen requires women to take combination tablets for 84 consecutive days, followed by 0.01 mg ethinyl estradiol tablets for a week. The treatment reduces the periods of withdrawal bleeding to four from 13 per year.

The U.S. Food and Drug Administration has approved Astellas Pharma US, Inc.’s new Vaprisol (conivaptan hydrochloride injection) premixed in 5% Dextrose. An arginine vasopressin (AVP) receptor antagonist, Vaprisol is the only drug approved and indicated for use in the treatment of patients with either kind of hyponatremia – euvolemic or hypervolemic. Its single-use (100ml) premixed formulation is available in an INTRAVIA(R) Container. The latest formulation will simplify preparation as it requires no mixing or measuring. Its safe usage period is six months longer than the original ampule formulation.

Meda’s new Astepro Nasal Spray (an improvement of the already available Astelin) has received the approval of the U.S. Food and Drug Administration. The new product is better tolerated by patients, caused lesser discomfort and was not tha bitter too. On the other hand,  relief from symptoms improved. Azelastine, the nasal antihistamine used for treating rhinitis is the active substance in it.

The U.S. Food and Drug Administration  has approved Bayer HealthCare’s Kogenate(R) FS for routine prophylaxis in children suffering from hemophilia. The drug will be used to reduce the incidence of joint damage and lower the frequency of bleeding episodes in patients below the age of 16 years. The approval makes Kogenate(R) FS the only factor VIII treatment regarded as safe and effective for routine prophylaxis by the FDA.The study on which the approval is based had special emphasis on index joints like elbow, knee and ankle that are most prone to bleeding.

The US Food and Drug Administration (FDA) has approved ProStrakan Group’s Sancuso®, ProStrakan’s novel, patented trans-dermal patch used to prevent chemotherapy-induced nausea and vomiting (CINV). Sancuso emerges as a patient-friendly treatment option which is both non-oral and non- invasive. The company hopes to launch the product in the United States by the end of the year 2008. It will be ProStrakan’s first ever product launch in the country.

The U.S. Food and Drug Administration (FDA) has approved Sanofi-aventis’ Nasacort AQ Nasal Spray for children aged 2-5 years old. The spray (triamcinolone acetonide) treats nasal symptoms associated with allergic rhinitis.The approval was given on the basis of the results of a placebo- controlled trial that found it to be safe and effective.

The FDA is reviewing the safety of Vytorin, which combines the cholesterol-lowering drugs Zocor and Zetia, after a clinical trial SEAS revealed that 4.1% of patients taking the drug died of some form of cancer. Although the impact is small, the FDA has alarmed doctors and patients about it. Meanwhile it has asked the manufacturers for further data. However, the FDA and the American Heart Association have said that the patients should not stop taking Vytorin or any other cholesterol drug as that may add to the risk of having a heart attack.

Shire Pharmaceuticals Inc. has received FDA approval for its Vyvanse drug for the treatment of adult attention deficit hyperactivity disorder (ADHD). In the clinical trials, Vyvanse (lisdexamfetamine dimesylate) significantly improved symptoms of inattention, hyperactivity and impulsivity in ADHD patients within one week of treatment. The trials also depicted that the drug’s efficacy at 30, 50 and 70-mg doses was significantly greater than placebo.

Spectrum Pharmaceuticals Inc. has received FDA approval for Levoleucovorin as a treatment for osteosarcoma. The drug has been approved for use after high-dose methotrexate therapy and to counteract the effects of impaired methotrexate elimination and an overdose of folic acid antagonists. The company intends to apply for FDA approval of Levoleucovorin in colon cancer and as an oral tablet by mid 2008.