Bausch & Lomb Receives FDA Approval Of Besivance(TM), New Topical Ophthalmic Antibacterial For The Treatment Of ... (Medical News Today)
Bausch & Lomb, a world leader in eye health, announced that the U.S. Food and Drug Administration (FDA) approved Besivance(TM) (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, commonly referred to as "pink eye.

FDA Approves Boston Scientific's Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System (Medical News Today)
Boston Scientific Corporation (NYSE: BSX) announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) Atom(TM) Paclitaxel-Eluting Coronary Stent System, a highly deliverable, next-generation drug-eluting stent (DES) specifically designed for treating small coronary vessels. It was approved for use in vessels as small as 2.

Read more about FDA Approvals - Bausch & Lomb Receives FDA Approval Of Besivance(TM), New Topical

Mylan Gets Tentative FDA Approval For Singulair (Pharmaceutical Business Review)
Mylan has declared that it has received tentative approval from FDA for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets. Montelukast Sodium Tablets are the generic version of Merck and Co.'s Singulair, which is used for the treatment of asthma and allergy.

Read more about Mylan Gets Tentative FDA Approval For Singulair (Pharmaceutical Business Review)

Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year 2009, Updates on FDA Inspection (redOrbit)
DETROIT, May 28 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) recorded net sales of $337.2 million during Fiscal 2009 compared to $350.4 million during Fiscal 2008.

FDA Approves New Total Ankle Replacement System (Medical News Today)
The U.S. Food and Drug Administration approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic. The device is the first of its type.

Warner Chilcott Announces FDA Acceptance Of NDA Submission For Low Dose Oral Contraceptive (PharmaceuticalOnline)
Warner Chilcott Limited (Nasdaq: WCRX ) announced today that the U.S. Food and Drug Administration (FDA) has filed for standard review the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The NDA for WC 3016 was submitted by its subsidiary, Warner Chilcott Company, LLC, on March 26, 2009.

Read more about FDA Approvals - Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year

FDA Officials Discuss Overhauling Agency In NEJM Perspective (Medical News Today)
"The FDA as a Public Health Agency," New England Journal of Medicine: In the perspective, FDA Commissioner Margaret Hamburg and Joshua Sharfstein, principal deputy commissioner of the agency, provide "a broad overview" of how they plan to "embrace" the agency's mission to protect the public's health. Hamburg and Sharfstein discuss their plans to work with other U.S.

Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year 2009, Updates on FDA Inspection (redOrbit)
DETROIT, May 28 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) recorded net sales of $337.2 million during Fiscal 2009 compared to $350.4 million during Fiscal 2008.

Read more about FDA Approvals - FDA Officials Discuss Overhauling Agency In NEJM Perspective (Medical News

FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products
The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action.

Read more about FDA, FTC Warn Public of Fraudulent 2009 H1N1 Influenza Products

Bra-shopping for birth control (The Cavalier Daily)
Shopping for birth control can feel a lot like bra shopping you have to choose the right fit, amount of padding, support, color, style the options can overwhelm you. Of course, once you find the perfect fit, you swear by it and end up with multiples of the same bra.

Read more about Bra-shopping for birth control (The Cavalier Daily) Shopping for birth

BIOFINITY (comfilcon A) Soft Contact Lens for Extended Wear
BIOFINITY is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel). (Approved: 11/19/2008)

Read more about BIOFINITY (comfilcon A) Soft Contact Lens for Extended Wear BIOFINITY

AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability (May 11)
A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.

Chang Farm Recalls Expired Chang Farm Bean and Soy Sprouts Because of Possible Health Risk (May 28)
Chang Farm, River Road, Whatley, MA is issuing a voluntary recall of Bean and Soy sprouts produced from Chang Farms, with specific expired date codes because of the possible presence of Listeria monocytogenes contamination.

Iovate Health Sciences U.S.A., Inc. Adds Hydroxycut-Branded Product Universal Product Codes to its Voluntary Nationwide Recall (May 7)
Iovate Health Sciences USA, Inc. of Blasdell, New York and Ontario, Canada announced today that it is adding Universal Product Codes (UPCs) with respect to the Hydroxycut-branded products sold in the United States and subject to the voluntary recall.

Read more about AS Medications Solution LLC. Announces a Nationwide Recall of All

FDA Approves Fanapt to Treat Schizophrenia
The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder. "Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA s Center for Drug Evaluation and Research. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives."

Read more about FDA Approves Fanapt to Treat Schizophrenia The U.S. Food and

FDA Approves Samsca to treat Hyponatremia
The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

Read more about FDA Approves Samsca to treat Hyponatremia The U.S. Food and

FDA staff questions J&J sedation device data (Reuters via Yahoo! News)
A study of Ethicon Endo-Surgery Inc's computerized system to help sedate patients undergoing a colonoscopy showed it was effective but other factors may have played a role, the U.S. Food and Drug Administration said in a memo released on Wednesday.

OCI Gets Brazilian FDA Approval For Monitors, Sensors (Pharmaceutical Business Review)
From the control room to the downstream processing ... Independent QA for Therapeutic Radiology and Oncol ...

Resignation of Ranbaxy CEO Creates New Headaches for Japanese Owner (BusinessWeek)
Over the weekend, Malvinder Singh, the chairman of India s Ranbaxy Laboratories, which is a major generics supplier to the US and Europe, resigned, taking two friendly members of the board with him.

Read more about FDA staff questions J&J sedation device data (Reuters via Yahoo!

FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months (Medical News Today)
Centocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application.

Warner Chilcott Announces FDA Acceptance Of NDA Submission For Low Dose Oral Contraceptive (PharmaceuticalOnline)
Warner Chilcott Limited (Nasdaq: WCRX ) announced today that the U.S. Food and Drug Administration (FDA) has filed for standard review the new drug application (NDA) for WC 3016, a low dose oral contraceptive. The NDA for WC 3016 was submitted by its subsidiary, Warner Chilcott Company, LLC, on March 26, 2009.

FDA Issues Advertising Guidelines On Product Risk Information (Medical News Today)
FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports.

Read more about FDA Approvals - FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application

FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application By Three Months (Medical News Today)
Centocor Ortho Biotech Inc. announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA(TM) (ustekinumab) to provide time for a full review of an amendment to the pending application.

FDA Officials Discuss Overhauling Agency In NEJM Perspective (Medical News Today)
"The FDA as a Public Health Agency," New England Journal of Medicine: In the perspective, FDA Commissioner Margaret Hamburg and Joshua Sharfstein, principal deputy commissioner of the agency, provide "a broad overview" of how they plan to "embrace" the agency's mission to protect the public's health. Hamburg and Sharfstein discuss their plans to work with other U.S.

Read more about FDA Approvals - FDA Extends Review Timeline For STELARA(TM) (ustekinumab) Biologic License Application

Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States Under Consent Decree
At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.

Read more about Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the

Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States Under Consent Decree
At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.

Read more about Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the

Amgen Exercises Option For Exclusive License To Cytokinetics' Cardiac Contractility Program That Includes CK-1827452 (PharmaceuticalOnline)
Cytokinetics Incorporated (Nasdaq: CYTK) and Amgen Inc. (Nasdaq: AMGN) today announced that Amgen has exercised its option to obtain an exclusive license, worldwide (excluding Japan), to Cytokinetics' cardiac contractility program.

KCI Announces FDA Clearance Of ABThera Open Abdomen Dressing (Medical News Today)
Kinetic Concepts, Inc. (NYSE: KCI) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ABThera Open Abdomen Dressing. Earlier this year, the FDA cleared the ABThera Open Abdomen Negative Pressure Therapy Unit.

Read more about FDA Approvals - Amgen Exercises Option For Exclusive License To Cytokinetics' Cardiac Contractility

Veracord and Parasoft Partner to Improve Compliance and Reduce Cost (PRWeb via Yahoo! News)
Veracord , (www.veracord.com), a privately held consulting company, announced today its partnership with Parasoft Corporation, a leading provider of automated software solutions.

Read more about Veracord and Parasoft Partner to Improve Compliance and Reduce Cost

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide
The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1 percent and Testim 1 percent, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).

Read more about Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes,

Bra-shopping for birth control (The Cavalier Daily)
Shopping for birth control can feel a lot like bra shopping you have to choose the right fit, amount of padding, support, color, style the options can overwhelm you. Of course, once you find the perfect fit, you swear by it and end up with multiples of the same bra.

Read more about Bra-shopping for birth control (The Cavalier Daily) Shopping for birth

Express SD Renal Monorail Premounted Stent System
The Express SD Renal Monorail Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Approved: 12/11/2008)

Read more about Express SD Renal Monorail Premounted Stent System The Express SD