May 2008 - FDA News

FDA Approvals - Terguride Receives FDA Orphan Drug Designation For The Treatment Of

Terguride Receives FDA Orphan Drug Designation For The Treatment Of Pulmonary Arterial Hypertension (Medical News Today)
Ergonex Pharma announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the treatment of pulmonary arterial hypertension (PAH). Terguride is currently being evaluated for PAH in a pivotal Phase II trial in Europe.

(AFX UK Focus) 2008-05-15 09:14 India's Zydus Cadila gets 4 product approvals from U.S. FDA (Interactive Investor)
MUMBAI (Thomson Financial) - Indian pharmaceuticals company Zydus Cadila said it received four product approvals from the U.S. Food and Drug Administration with a market size of $6.498 billion.

FDA Approves First Generic Ropinirole The U.S. Food and Drug

FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.

Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc.

Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician s stock. The FDA will work with Bayer to ensure a smooth and complete process.

Remove kids from underage sex: Stuckey (The West Australian) Queensland

Remove kids from underage sex: Stuckey (The West Australian)
Queensland authorities should remove children who have underage sex from dangerous and illegal situations, instead of implanting them with contraceptive devices, the state opposition says.

Schering-Plough posts 48% drop (Asbury Park Press)
Schering-Plough Corp., the maker of the Vytorin and Zetia cholesterol pills, said first-quarter profit fell 48 percent, less than analysts expected, on costs for acquiring Organon Biosciences NV.

A mom's guide to birth control (CNN.com)
Question: I've always been on the Pill, but now I'm breastfeeding. That means I can't go back on it, right?

ARCHITECT CORE-M The ARCHITECT CORE-M is a lab test

ARCHITECT CORE-M
The ARCHITECT CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. (Approved: 11/6/2007)

Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff

Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28)
Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium.

Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15)
Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN.

Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6)
Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.

FDA Approves First Compact Heart Assist Device The U.S. Food

FDA Approves First Compact Heart Assist Device
The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.

Paragon CRT(R) Inquiries Increase with Recent FDA Hearing on Dangers

Paragon CRT(R) Inquiries Increase with Recent FDA Hearing on Dangers of LASIK (Centre Daily Times)
Paragon Vision Sciences announced a surge in inquiries for Paragon CRT(R) contact lenses, which gently reshape the cornea during sleep, temporarily correcting nearsightedness. The increase follows the April 25 FDA hearing regarding the dangers of LASIK surgery.

Arbios Receives Approval From The FDA To Initiate Pivotal Trial For SEPET(TM) Liver Assist Device (Medical News Today)
Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced that the Company has received approval from the U.S.

FDA Approvals - (AFX UK Focus) 2008-05-15 09:14 India's Zydus Cadila gets 4

(AFX UK Focus) 2008-05-15 09:14 India's Zydus Cadila gets 4 product approvals from U.S. FDA (Interactive Investor)
MUMBAI (Thomson Financial) - Indian pharmaceuticals company Zydus Cadila said it received four product approvals from the U.S. Food and Drug Administration with a market size of $6.498 billion.

Zydus Cadila gets four US FDA approvals (PharmaBiz)
Zydus Cadila has received four product approvals from US FDA. The group has received approvals to market Pravastatin' sodium tablets USP 10, 20, 40 and 80 mg and tentative approvals for Escitalopram Oxalate' tablets 5,10 and 20 mg, Losartan Potassium and Hydroeblorthiazide tablets 50 mgIl2.5 mg and 100 mgtl5 mg and Anastrazole tablets 1mg.

FDA Approvals - St. Jude Medical Announces FDA and European CE Mark Approvals

St. Jude Medical Announces FDA and European CE Mark Approvals of the IsoFlex Optim Pacing Lead (Centre Daily Times)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of the IsoFlex(R) Optim(TM) pacing lead. The small-diameter lead is built on the proven IsoFlex(R) pacing lead platform, and features the company's exclusive Optim(R) insulation material. With the addition of Optim insulation to IsoFlex leads, all St. Jude Medical pacemaker ...

FDA Approves Taclonex Scalp(R) Once Daily Therapy For Treatment Of Moderate To Severe Scalp Psoriasis (Medical News Today)
Warner Chilcott and LEO Pharma announced that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Taclonex Scalp(R) (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension. LEO Pharma submitted the NDA for Taclonex Scalp(R) to the FDA in July 2007.

FDA Approvals - St. Jude Medical Announces FDA Approval of Next-Generation Remote Monitoring

St. Jude Medical Announces FDA Approval of Next-Generation Remote Monitoring and Data Management System for ... (wallstreet:online AG)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) approval

FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis (PR Newswire via Yahoo! Finance)
Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration has approved the New Drug Application for Taclonex Scalp Topical Suspension. LEO Pharma submitted the NDA for Taclonex Scalp to the FDA in July 2007.

FDA Approves Relistor for Opioid-Induced Constipation The U.S. Food and

FDA Approves Relistor for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

FDA Approves Amitiza for IBS-C The U.S. Food and Drug

FDA Approves Amitiza for IBS-C
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

invivodata's ePRO Solution Captures Primary Efficacy Data Supporting Supplemental Approval

invivodata's ePRO Solution Captures Primary Efficacy Data Supporting Supplemental Approval of Sucampo's AMITIZA for a ... (Centre Daily Times)
invivodata inc., the industry leader in electronic patient reported outcomes (ePRO) solutions and services for global clinical research, today announced that its ePRO solutions -- DiaryPRO(R) and SitePRO(R) -- captured primary efficacy data that supported the recent U.S. Food and Drug Administration's (FDA) supplemental approval of Sucampo Pharmaceutical Inc.'s AMITIZA(R) (lubiprostone) 8 mcg ...

I-Flow To Present At The Bank of America 2008 Health Care Conference on Tuesday, May 13, 2008 at 11:20 a.m. PDT (Centre Daily Times)
I-FLOW CORPORATION (NASDAQ:IFLO) announced today that it will address institutional shareholders at the Bank of America 2008 Health Care Conference on Tuesday morning, May 13, 2008 at 11:20 a.m. PDT.

FDA Approvals - St. Jude Medical Announces FDA Approval of Next-Generation Remote Monitoring

St. Jude Medical Announces FDA Approval of Next-Generation Remote Monitoring and Data Management System for ... (wallstreet:online AG)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) approval

Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device (PR Newswire via Yahoo! Finance)
Arbios Systems, Inc. announced today that the Company has received approval from the U.S. Food and Drug Administration of an Investigational Device Exemption to begin the pivotal clinical trial for SEPET, Arbios' extracorporeal liver assist device for blood purification of acutely ill patients suffering from chronic liver disease.

FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis (PR Newswire via Yahoo! Finance)
Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration has approved the New Drug Application for Taclonex Scalp Topical Suspension. LEO Pharma submitted the NDA for Taclonex Scalp to the FDA in July 2007.

FDA Orders Pet Food Maker to Obtain Emergency Operating Permit

FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.

Schering-Plough posts 48% drop (Asbury Park Press) Schering-Plough Corp., the

Schering-Plough posts 48% drop (Asbury Park Press)
Schering-Plough Corp., the maker of the Vytorin and Zetia cholesterol pills, said first-quarter profit fell 48 percent, less than analysts expected, on costs for acquiring Organon Biosciences NV.

A mom's guide to birth control (CNN.com)
Question: I've always been on the Pill, but now I'm breastfeeding. That means I can't go back on it, right?

ProDisc™-C Total Disc Replacement The ProDisc?-C Total Disc Replacement is

ProDisc™-C Total Disc Replacement
The ProDisc?-C Total Disc Replacement is a device made from metal and plastic that is placed between two adjacent vertebral bodies (neck bones) to replace a diseased cervical disc. The ProDisc?-C Total Disc Replacement consists of three parts... (Approved: 12/17/2007)

DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because

DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)
The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).

KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)
KFC Corporation is voluntarily recalling its Double Chocolate Chip Cakes because they contain eggs, milk, wheat, soy ingredients and possibly traces of tree nuts, and are not individually labeled with ingredient information.

FDA Approvals - Senate Version Of Supplemental War Appropriations Bill Would Delay Medicaid

Senate Version Of Supplemental War Appropriations Bill Would Delay Medicaid Regulations, Increase FDA Funds (Medical News Today)
The Senate Appropriations Committee on Thursday plans to mark up a supplemental war appropriations bill that will include language to block for one year seven new Medicaid regulations proposed by the Bush administration, as well as additional funds for FDA, CQ Today reports (Higa, CQ Today, 5/7).

Lev Pharmaceuticals Announces Cinryze(TM) Complete Response Submission Accepted For Review By FDA (Medical News Today)
Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) announced that the U.S. Food and Drug Administration (FDA) has accepted for review Lev's complete response submission for Cinryze (C1 inhibitor), the Company's lead product candidate.