Pharmaceutical Product Guide

FDA approves hGH needle-free injection by Teva

Kimberly O'Brien — Fri, 10 Jul 2009 05:01:08 +0000

The FDA has approved Teva Pharmaceuticals’ hGH needle-free injection, relieving kids requiring medication to enhance their human growth hormone (hGH) levels from fright and pain of shots. Needle-free injectors boost a fine stream of medicated liquid through the skin to the subcutaneous fatty tissue. This liquid is then absorbed by the body.

FDA issues warning on anti-smoking drugs

Kimberly O'Brien — Fri, 03 Jul 2009 04:18:28 +0000

The FDA has issued a warning for the anti-smoking drugs Chantix and Zyban as bizarre behavior, including suicide, has been seen in people taking these medicines. Both drugs will now carry “black box” labels warning informing people that those consuming these drugs should be closely watched for signs of suicidal thoughts, depression, hostility or other changes in behavior.

Watson Pharmaceuticals’ arm gets nod from U.S. FDA for Azurette Tablets

Kimberly O'Brien — Fri, 02 Jan 2009 13:26:58 +0000

Watson Pharmaceuticals, Inc. has notified that its unit, Watson Laboratories, Inc. has received final nod from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg. The latest drug is the generic equivalent to Duramed Pharmaceuticals’ Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy. California-based pharmaceutical firm intends to launch the product in early January 2009 under the trade name Azurette (TM).

MDRNA Announces Tentative FDA Approval Of Generic Calcitonin-Salmon Nasal Spray

Kimberly O'Brien — Thu, 18 Dec 2008 12:08:04 +0000

MDRNA, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA’s Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex’s 180-day exclusivity period, or June 2009. MDRNA’s generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $147 million in 2007.

InterCure Announces Launch of RESPeRATE Ultra

Kimberly O'Brien — Tue, 09 Dec 2008 07:32:41 +0000

InterCure Ltd. has announced the U.S. release of its next generation hypertension treatment device, RESPeRATE Ultra. The RESPeRATE Ultra was designed with input from thousands of RESPeRATE users. Featuring a large, enhanced display, fewer buttons and simple menus, the unit was crafted to not only provide the same blood pressure reduction results as its predecessor, but also provide an enhanced, pleasurable device-guided breathing experience. The RESPeRATE Ultra also includes a first-of-its-kind interactive tutorial that guides the user to quickly learn to use the device to most effectively lower his or her blood pressure.

New Treatment Hope For People With Recurring Depression

Kimberly O'Brien — Tue, 02 Dec 2008 12:21:48 +0000

Research conducted at University of Exeter, shows for the first time that a group-based psychological treatment, Mindfulness Based Cognitive Therapy (MBCT), could be a viable alternative to prescription drugs for people suffering from long-term depression. In a study, published in the Journal of Consulting and Clinical Psychology, MBCT proved as effective as maintenance anti-depressants in preventing a relapse and more effective in enhancing peoples’ quality of life. The study also showed MBCT to be as cost-effective as prescription drugs in helping people with a history of depression stay well in the longer-term.

AngioDynamics to unveil new varicose vein therapy brand VenaCure EVLT

Kimberly O'Brien — Tue, 18 Nov 2008 15:41:57 +0000

AngioDynamics Inc. has announced its plan to launch a new varicose vein therapy brand, VenaCure EVLT. The new brand will encompass the best of AngioDynamics’ VenaCure(R) product line as well as EVLT(R), a product line which AngioDynamics recently rescued from the bankruptcy of Diomed Inc. The product is an outpatient alternative to otherwise painful and invasive surgery for patients. VenaCure EVLT provides physicians continuous support from AngioDynamics to develop their clinical practices and provide patients with the best treatment available.

FDA nod to CV Therapeutics’ Ranexa for treatment of chronic angia

Kimberly O'Brien — Thu, 06 Nov 2008 15:46:34 +0000

The U.S. Food and Drug Administration has approved CV Therapeutics’ Ranexa (ranolazine) for treating chronic angina. The changed labeling also informs that Ranexa showed better results for conditions like arrhythmias, new onset atrial fibrillation and bradycardia (dangerously slow heartbeat in patients of coronary artery disease). Also, the labeling mentions that Ranexa lowers hemoglobin A1c (HbA1c) in diabetes patients. The drug can now be used as a part of optimal therapy. Neither it reduces heart rate nor blood pressure. Unlike other long acting nitrates, Ranexa is prescribed for patients taking oral treatments for erectile dysfunction.

FDA approval to Apidra(R) for diabetic children

Kimberly O'Brien — Fri, 31 Oct 2008 06:21:01 +0000

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.

FDA approves Duramed’s LoSEASONIQUE(R) oral contraceptive

Kimberly O'Brien — Wed, 29 Oct 2008 06:43:40 +0000

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.