Hotspur Technologies, Inc. has announced that it has received FDA clearance for the first three commercial products in its portfolio. These products are based on Hotspur’s unique and groundbreaking technology that makes dialysis access interventional and peripheral vascular procedures that open blood vessels less expensive, more efficient, and less invasive for patients. These new Hotspur devices are focused on solving some of the key challenges resulting from two types of medical procedures for restoring bloodflow.

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Calibra Medical has announced that it has received 510(k) clearance from the FDA to market its Finesse™ insulin patch-pen for up to three-day use with Novo Nordisk’s Novolog® rapid acting insulin. Combining the mealtime therapy-adherence benefits of insulin pumps with the simplicity and affordability of syringes and pens, Calibra’s novel bolus-only patch-pen is a small, adhesively attached, flat device that can be operated discretely through clothing to deliver mealtime, snack time, and correction bolus insulin.

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Eisai Inc. has announced that the FDA has accepted for review Eisai’s NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL). The proposed indication is for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children four years and older and adults. The application is based on data from a study designed to demonstrate the bioequivalence of the oral suspension formulation to the currently marketed BANZEL tablet formulation (400 mg).

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A new diet pill, Lorcaserin, manufactured by Arena Pharmaceuticals has proven safe and is expected to obtain FDA approval. The now experimental diet pill has proven effective in a two year trial that included nearly 3200 participants. The only noted side effects were headaches and dizziness, according to a study in the New England Journal of Medicine.

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Mylan Inc. received the FDA approved for its generic version of the osteoarthritis and rheumatoid arthritis drug Nabumetone. The FDA approval allows Mylan to sell 500 milligram and 750 milligram tablets of Nabumetone. It is a nonsteroidal anti-inflammatory drug, which is a popular type of arthritis and inflammation treatment.

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The FDA has approved an expanded age range for a methylphenidate transdermal system (Daytrana; Shire, under license from Noven Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Previously approved for use in children aged 6 to 12 years, the methylphenidate patch is indicated as an integral part of a total treatment program that may include psychological, educational, and social measures.

Roxane Laboratories has received approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the FDA. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies across the US. Roxane Laboratories’ Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.

FDA Advisory Committee affirmed the drugs positive benefit/risk profile and unanimously voted in favor of the approval of FTY720 (fingolimod) as the treatment in relapsing remitting multiple sclerosis. FTY720, potentially first in a new class of MS therapy, represents a significant advance as an efficacious oral treatment for people with relapsing remitting MS.

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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