FDA Approved

01.02.2012 FDA Approved No Comments

2011 FDA Approvals

By Liz Jones Hollis and Jennifer Levin
Welcome to our annual look back at FDA approvals. 2011 was a big year for drugmakers seeking to get their innovative products approved, as the FDA was busy. In fact, the agency approved 30 new drugs last year (a 7-year high). Among the lucky bunch who got an FDA nod were Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK), both of which snagged three approvals each.

read more

19.11.2011 FDA Approved No Comments

Tandem Insulin Pump FDA Approved

20111119-213305.jpg by Liz Jones Hollis

The FDA has cleared San Diego-based Tandem Diabetes Care’s t:slim insulin delivery system (pictured). And according to the company, t:slim is the first pump with a color touch screen and will be the smallest such system once it is commercially launched in the first half of 2012.

The t:slim system was designed to ease diabetes management. User-friendly features include an eco-friendly rechargeable battery and USB connectivity to a web-based therapy management software.

“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort.’ The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.”

Of the approximate 1.5 million people in the U.S. with Type 1 diabetes, roughly 20% to 30% use an insulin pump, the company says in a statement, citing industry estimates. Tandem thinks the enhanced ease of use and attractive design of its offering will encourage more patients to consider insulin pump therapy.

The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.

22.06.2011 FDA Approved No Comments

Pain Relief for Anal Fissures

FDA Approves New Drug for Chronic Anal Fissure Pain
Mark Crane
Authors and Disclosures
June 22, 2011 — The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.

The ointment will be the only FDA-approved prescription product for patients with this condition, according to the company. Marketed under the name Rectogesic, the ointment is already approved in the European Union and has been outlicensed outside Europe by ProStrakan to commercial partners in 34 countries worldwide.

“The pain associated with anal fissures can be unrelenting and debilitating. Prompt initiation of treatment by primary care practitioners, gynecologists, gastroenterologists and surgeons alike is critical to a patient’s wellbeing,” Scott Berry, MD, colorectal surgeon and the principal investigator on one of Rectiv’s clinical trials, said in a news release. “Now we have an effective and easy-to-use topical ointment which allows grateful patients to resume their daily lives.”

Approximately 700,000 people in the United States receive a diagnosis of or treatment for an episode of anal fissures each year. An anal fissure is a small tear in the skin that lines the anus, and it can occur in many ways, such as passing large or hard stools, straining during a bowel movement, or following an episode of diarrhea. When an anal fissure occurs, it typically causes severe pain and bleeding with bowel movements. Chronic anal fissure has been shown to significantly affect patients’ quality of life, the company said. An episode can take 6 to 8 weeks to heal, and if healing does not occur surgery may be required.

ProStrakan expects Rectiv to be available in the United States in the first quarter of 2012.

ProStrakan, based in Galashiels, Scotland, and Bedminster, New Jersey, is a subsidiary of Kyowa Hakko Kirin Co. Ltd., a Japan-based global specialty pharmaceutical company.

Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.

04.06.2010 blog, FDA Approved No Comments

ProGEL™ Pleural Air Leak Sealant

Product name: ProGEL™ Pleural Air Leak Sealant
PMA Applicant: NeoMend, Inc
Address: 60 Technology Dr., Irvine, CA 92618
Approval Date: January 14, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010047a.pdf

What is it?
The ProGEL™ Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure techniques, (that is, sutures or staples) for open resection of lung tissue. read more

04.06.2010 blog, FDA Approved 1 Comment

Thoratec HeartMate II LVAS

Picture of a Thoratec HeartMate II LVASThis is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

What is it? The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart’s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes a pump implanted inside the patient’s body and components that remain outside the patient’s body. The pump controller and batteries are worn outside the patient’s body. The system also includes a battery charger/power supply and monitor that remain outside the body. read more

04.06.2010 blog, FDA Approved No Comments

Medtronic Melody® Transcatheter Pulmonary Valve

Picture of the device.

FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Medtronic Melody® Transcatheter Pulmonary Valve (Model PB10) and Medtronic Ensemble® Transcatheter Valve Delivery System (NU10)
Manufacturer: Medtronic Heart Valves, Inc.
Address: 1851 Deere Avenue , Santa Ana, California 92705
Approval Date: 25 January 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/H080002a.pdf

What is it?
The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. The Melody valve is made from a cow’s jugular vein valve that is sewn into a small metal stent (scaffolding). The Melody valve comes in sizes 18, 20, and 22mm diameters and has a stent length of 28mm. The Medtronic Ensemble® Transcatheter Valve Delivery System is a catheter (long tube with small diameter) that helps guide the Melody into the heart. The Ensemble delivery system has catheters with balloon sizes of 18, 20, and 22mm. read more

04.06.2010 blog, FDA Approved No Comments

Express® LD Iliac Premounted Stent System

Photo of Express® LD Iliac Premounted Stent SystemThis is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Express® LD Iliac Premounted Stent System
Manufacturer: Boston Scientific Corporation
Address: One Boston Scientific Place, Natick, MA  01760
Approval Date: March 5, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090003a.pdf

What is it?
The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube.  The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter.  The Express LD Iliac Stent acts like a support (scaffold) by holding open an artery in the pelvis or legs (iliac artery) to maintain adequate blood flow to the legs. read more

04.06.2010 blog, FDA Approved No Comments

Medtronic Vascular Complete® SE Vascular Stent System

Picture of Complete® SE Vascular Stent System

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval

Product Name: Complete® SE Vascular Stent System (20-100mm lengths)
Manufacturer: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: March 17, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090006a.pdf

What is it?
The Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries).  It consists of two parts, the stent and the delivery system.  The stent is an implant constructed of a nickel-titanium alloy (nitinol) tubing and laser-cut into a mesh shape.  The stent is mounted within a long, thin, tube-like device called the delivery catheter. read more

04.06.2010 blog, FDA Approved No Comments

Quick-Close® Vascular Suturing System

Picture of a Quick-Close® Suture Applier.
Quick-Close® Suture Applier
Picture of a Quick-Ti® Cinch Applier.
Quick-Ti® Cinch Applier

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Quick-Close® Vascular Suturing System
PMA Applicant: Interventional Therapies, LLC
Address: 1 Gorham Island, Westport, CT 06880
Approval Date: April 8, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080029a.pdf

What is it?
The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). It consists of the Quick-Close Suture Applier and the Quick-Ti Cinch Applier. The Suture Applier has a pistol grip shape and contains a single strand of an artificial suture (polybutester [Novafil] ™) fitted with stainless steel rings. The Cinch Applier has a syringe-type shape with an extended handle. read more

04.06.2010 blog, FDA Approved No Comments

Softec HD Aspheric Posterior Chamber Intraocular Lens

Image of a Softec HD Aspheric Posterior Chamber Intraocular Lens.This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Softec HD Aspheric Posterior Chamber Intraocular Lens
PMA Applicant: Lenstec, Inc.
Address: 1765 Commerce Ave N, St. Petersburg, Florida 33716
Approval Date: April 12, 2010
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf9/P090022a.pdf

What is it?
The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery.Exit Disclaimer A cataract is a gradual thickening, hardening and clouding of the eye’s lens, resulting in loss of vision. Cataracts are often the result of aging, but can have other causes. read more