Medical Product Guide» FDA approvals

Ascension Orthopedics Receives FDA Approval For TITAN™ Modular Total Shoulder System

Jim Marino — Fri, 24 Sep 2010 15:05:12 +0000

Ascension Orthopedics, Inc. announces FDA approval to market the TITAN™ Modular Total Shoulder System. This system redefines modularity by providing multiple surgical solutions for shoulder arthroplasty with one implant system. The TITAN Modular Total Shoulder System offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty. The modularity of the system allows the surgeon to independently select distal stems and proximal bodies that best match the patient’s anatomy and bone quality.

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Hotspur Technologies Receives FDA 510(k) Clearance For First Three Product Lines Based On its Unique Technology

Jim Marino — Wed, 04 Aug 2010 04:59:12 +0000

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 Gains FDA Clearance To Market Finesse(TM) Insulin Patch-Pen For Three-Day Use With Novolog(

Jim Marino — Wed, 28 Jul 2010 06:13:07 +0000

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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FDA Accepts BANZEL(R) (Rufinamide) Oral Suspension NDA For Review

Jim Marino — Wed, 21 Jul 2010 08:27:58 +0000

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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Lorcaserin To Get FDA Approval

Jim Marino — Fri, 16 Jul 2010 09:14:32 +0000

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 Receives FDA Approval For Nabumetone

Jim Marino — Fri, 16 Jul 2010 09:09:23 +0000

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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FDA Approves Daytrana for ADHD

Jim Marino — Fri, 09 Jul 2010 19:19:32 +0000

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 Receives FDA Approval For Anastrozole Tablets

Jim Marino — Fri, 09 Jul 2010 19:14:49 +0000

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.

BioElectronics Receives New OTC Product Approvals

Jim Marino — Wed, 30 Jun 2010 14:35:59 +0000

BioElectronics Corporation has announced that its Allay™ Menstrual Pain Therapy product has been approved for over the counter sale by Health Canada for the treatment of menstrual pain symptoms, including cramps and abdominal pain, and for reducing the use of pain medication associated with menstruation, while ActiPatch™ is now approved by the South Korea Food and Drug Administration (KFDA) for reduction of muscle pain.

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FDA Advisory Committee Unanimously Votes For the Approval of FTY720

Jim Marino — Fri, 11 Jun 2010 18:36:23 +0000

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.