The FDA has approved GlaxoSmithKline’s Lamictal XR extended-release tablets as once-a-day, add-on therapy for epilepsy in patients over 13 years of age suffering from primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial onset seizures for patients in this age group.

The study depicted that the addition of Lamictal XR in therapy reduced the seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures.

Microlife Medical Home Solutions, Inc. has announced The Biggest Loser medical staff will implement the MedGem indirect calorimeter to assess metabolic changes in program contestants. The MedGem handheld indirect calorimeter is an FDA-cleared, Class II, medical device that assesses metabolic rate by measuring a patient’s resting oxygen consumption. Resting metabolic rate varies dramatically between individuals. Until recently, most healthcare providers would estimate RMR using complicated estimation equations.

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Dr. Emad Kandil of Tulane University School of Medicine is one of the first in the country to perform a new form of endoscopic surgery that uses a small incision under the arm to remove all or a portion of the thyroid or parathyroid glands without leaving a scar on the neck. Not only is Dr. Kandil one of the few surgeons in the US trained to perform the surgery, but he chairs an annual symposium at Tulane to teach surgeons how to perform minimally invasive thyroid surgery and will be teaching the technique to doctors from across the country.

Traditional surgery usually involves a fairly long incision at the base of the neck. The new Robotic transaxillay approach means that the patient won’t have a scar on the neck, and for many people, this is enough to try this novel technique.

Robotic gasless transaxillary thyroidectomy is a newly developed minimally invasive surgical technique to remove all or part of the thyroid. This was developed by Dr. Chung in South Korea. With this new technique, a small incision is made under the arm. Before its development, there were different options for thyroid surgery: conventional open surgery, endoscopic surgery with a shorter neck incision or transaxillary approach with gas insufflation. Conventional open surgery involves a scar on the neck. Endoscopic or videoscopic techniques are done using a small camera, however, this still involves a neck scar. The neck scar is shorter in these approaches, but still there is an incison in the neck. With the new method, there is no scar on the neck whatsoever.

Robotic gasless transaxillary thyroidectomy eliminates the neck scar by accessing the thyroid gland through a hidden incision under the arm. The special designed robotic arms allow the surgeon to operate with very precise movements. Robotic instruments do work just like hands. However, they are amazingly small. The robot is completely under the control of the surgeon. The robotic system also proides 3D visualization, with a special designed high-definition camera with an excellent magnification of 10x.

This technique is not only about avoiding an incision and a scar on the neck. From a surgical standpoint, safely performing these procedures depends on clear visualization of important nearby structures, including nerves and parathyroid glands.

Initially, robotic approach was done with gas insufflation to the neck area, however this gas can be retained, which can cause retained pneumomediastinum or subcutaneous air with uncomfortable crepitations. The patient may experience significant metablic problems with CO2 retention. The gas eventually will be absorbed, but it can cause siginificant discofort until this completely absorbed. These patients needed to stay hospitalized longer than they used to with conventional surgery for observation. With this new approach, gas insufflations is avoided, so Co2 retention complications are also avoided.

This procedure was recently approved by FDA and is is proven to be a safe approach. However, special training and experience with robotic surgery is a must to proceed. With more experience, more patients can be offered this approach. Large thyroid nodules over 4cm were initially not candidates for this procedure before, however, now the surgery is able to be offered to these patients with an excellent outcome.

Palomar Medical Technologies Inc. will go ahead with the commercialization of its FDA-cleared home-use laser device for treatment of periorbital wrinkles, despite the termination of its commercialization agreement with Johnson & Johnson. Palomar plans to launch the products during the second half of next year. With the agreement cancellation, JJCC avoids having to commit to the significant level of funding required to successfully launch a new product into the mass market.

The FDA has directed Glenmark Generics Inc and three other manufacturers to stop marketing unapproved codeine sulphate tablets in the US market. The drug is an old narcotics product widely used to treat pain. These products, marketed in 30mg and 60mg form, lack FDA approval and the agency has no evidence that they are safe and effective.

A small inhaler and insulin powder created by the MannKind Corporation is awaiting the FDA’s response for marketing purposes. After the FDA gives marketing approval for the insulin powder, called Afresa, patients can use a new, palm-size device that may let them discretely inhale a dose of insulin instead of using a needle. Afresa is inhaled into the lungs, where it dissolves and travels into the bloodstream.

Salix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.

Theravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

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.