October 2007 - FDA News

FDA Approves Change in Storage Conditions for Humate-P The U.S.

FDA Approves Change in Storage Conditions for Humate-P
The U.S. Food and Drug Administration today approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).

FDA Approvals - Indoco Remedies net profit up 31.67% (PharmaBiz) The Mumbai based

Indoco Remedies net profit up 31.67% (PharmaBiz)
The Mumbai based leading pharmaceutical company Indoco Remedies has achieved better performance in the first quarter ended September 30, 2007. The company has posted 31.67 per cent in net profit to Rs 10.85 crore from Rs 8.24 crore in the corresponding period of last year.

BodyTel Scientific Provides Update On GlucoTel Regulatory Status (PrimeNewswire via Yahoo! Finance)
HENDERSON, Nev., Oct. 29, 2007 -- BodyTel Scientific, Inc. is pleased to announce significant progress with respect to securing both CE and FDA regulatory approvals for its GlucoTel System.

FDA Approves New Drug to Treat Complicated Urinary Tract and

FDA Approves New Drug to Treat Complicated Urinary Tract and Intra-Abdominal Infections
The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections.

FDA Seeks Nominations for Reagan-Udall Foundation The U.S. Food and

FDA Seeks Nominations for Reagan-Udall Foundation
The U.S. Food and Drug Administration is seeking nominations from patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to serve on the board of directors of the newly created Reagan-Udall Foundation.

Schering-Plough's Shares Fall After Earnings Miss (Update3) (Bloomberg.com) Oct. 22

Schering-Plough's Shares Fall After Earnings Miss (Update3) (Bloomberg.com)
Oct. 22 (Bloomberg) -- Schering-Plough Corp. fell the most in more than six years in New York trading after third-quarter earnings missed analysts' estimates because of higher research costs and slower growth for its cholesterol drugs.

NY proposes $175 billion for transportation as deficit grows (AM New York)
A decline in tax revenues in a slowing economy will result in a $4.3 billion budget deficit, $651 million worse than projected in July, according to a budget report issued Tuesday.

Pharmaceutical, Healthcare & Life Sciences (Mondaq) In the face of

Pharmaceutical, Healthcare & Life Sciences (Mondaq)
In the face of both substantive and procedural concerns, the Centers for Medicare & Medicaid Services ("CMS") has decided not to adopt significant changes to the Medicare clinical trial national coverage policy that it had proposed on July 19, 2007. Instead, CMS s July 9, 2007 final clinical trial coverage policy stands.

From Information Silo to Bridge, Part 2: Creating a UDI System (Medical Device Link)
As discussed in Part 1 of this article (published in October 2007), FDA is looking to break down the silo mentality that plagues the medical device industry supply chain.

IBI Therapy? Cool Path? Ablation Catheter and IBI 1500T9 RF

IBI Therapy? Cool Path? Ablation Catheter and IBI 1500T9 RF Generator
A catheter is a flexible hollow plastic tube about the thickness of a piece of spaghetti that can be placed into a body cavity. An ?ablation catheter? is a catheter used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to... (Approved: 3/16/2007)

House of Thaller, Inc. Recalls Smoked Salmon Dip Because of

House of Thaller, Inc. Recalls Smoked Salmon Dip Because of Possible Health Risk (Oct. 29)
The product was distributed to AL, AR, GA, IL, KS, KY, MI, MO, MS, NC, NE, OH, SC, TN, TX, VA, and WV. The product reached consumers packed under the Kroger brand and was sold in the Kroger Seafood Department.

Wegmans Announces Voluntary Recall of 18 oz. (6-roll pack) Wegmans Food You Feel Good About Country Wheat Rolls (Oct. 5)
This product is being recalled because the package may actually contain potato rolls, which contain a milk allergen not declared on the label.

TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements (Sept. 12)
FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

FDA Approvals - ATS Medical Receives FDA Clearance For ATS Simulus Semi-Rigid Annuloplasty

ATS Medical Receives FDA Clearance For ATS Simulus Semi-Rigid Annuloplasty Ring (Medical News Today)
ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced U.S. Food and Drug Administration (FDA) clearance for the ATS Simulus(R) Semi-Rigid Annuloplasty Ring. [click link for full article]

Ranbaxy gets tentative US FDA nod for Valsartan pills (PharmaBiz)
Ranbaxy Laboratories Ltd (RLL), has received tentative approval from the US Food and Drug Administration to manufacture and market Valsartan tablets, 40 mg, 80 mg, 160 mg and 320 mg. Total annual market sales for Valsartan tablets were $1.3 billion (IMS - MAT: June 2007).

FDA Issues Early Communication About an Ongoing Safety Review of

FDA Issues Early Communication About an Ongoing Safety Review of Aprotinin Injection
The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection (marketed as Trasylol), a drug used to control bleeding during heart surgery.

FDA Approvals - Genzyme gets US FDA marketing nod for Renvela (PharmaBiz) Genzyme

Genzyme gets US FDA marketing nod for Renvela (PharmaBiz)
Genzyme Corp. announced that the US Food and Drug Administration have granted marketing approval for Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

ATS Medical Receives FDA Clearance For ATS Simulus Semi-Rigid Annuloplasty Ring (Medical News Today)
ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced U.S. Food and Drug Administration (FDA) clearance for the ATS Simulus(R) Semi-Rigid Annuloplasty Ring. [click link for full article]

FDA, med-test makers tangle over approvals (BizJournals)
Sin Hang Lee isn't afraid. The Connecticut pathologist, who spends his spare time developing viral diagnostics, says the U.S. Food and Drug Administration has failed to give him guidance on how one of his tests should be regulated. He mounted a lawsuit against the venerable agency last week.

FDA Announces Initiative to Bolster Generic Drug Program The U.S.

FDA Announces Initiative to Bolster Generic Drug Program
The U.S. Food and Drug Administration outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers.

FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for

FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with ... (The San Francisco Examiner)
COLLEGEVILLE, Pa. ( Map ) - COLLEGEVILLE, Pa., Oct. 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's supplemental New Drug Application (sNDA) for its first-in-class antibiotic Tygacil(R) (tigecycline) for the treatment of patients with community-acquired ...

Read my lips (The Express-Times)
When it comes to lipstick, red is good -- but lead is bad. And lead, according to a recent report, is found in small amounts as an ingredient in the pigment that provides the color in some lipstick brands. That's why deep-red lipsticks in particular have been singled out for testing.

FDA Approvals - ATS Medical Shares Rise on FDA Approval (AP via Yahoo!

ATS Medical Shares Rise on FDA Approval (AP via Yahoo! Finance)
Cardiac surgery products maker ATS Medical Inc. said Friday it received Food and Drug Administration clearance for its ATS Simulus Semi-Rigid Annuloplasty Ring, which is used to repair heart valves.

ATS Medical Receives FDA Clearance for ATS Simulus Semi-Rigid Annuloplasty Ring (PR Newswire via Yahoo! Finance)
ATS Medical, Inc. , manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration clearance for the ATS Simulus Semi-Rigid Annuloplasty Ring.

FDA Acts to Ensure Thyroid Drugs Don t Lose Potency Before

FDA Acts to Ensure Thyroid Drugs Don t Lose Potency Before Expiration Date
The U.S. Food and Drug Administration is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life.

Schering-Plough's Shares Fall After Earnings Miss Estimates (Bloomberg.com) Oct. 22

Schering-Plough's Shares Fall After Earnings Miss Estimates (Bloomberg.com)
Oct. 22 (Bloomberg) -- Schering-Plough Corp. fell the most in more than six years in New York trading after the drugmaker's earnings missed analysts' estimates.

FDA Approvals - ATS Medical Receives FDA Clearance for ATS Simulus Semi-Rigid Annuloplasty

ATS Medical Receives FDA Clearance for ATS Simulus Semi-Rigid Annuloplasty Ring (PR Newswire via Yahoo! Finance)
ATS Medical, Inc. , manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration clearance for the ATS Simulus Semi-Rigid Annuloplasty Ring.

KV Pharmaceutical Announces FDA Approval for Morphine ER 100 mg and 200 mg Tablets (The San Francisco Examiner)
ST. LOUIS , Oct. 25 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it has received approval from the U.S.

ATS wins approval on heart device (bizjournals.com via Yahoo! Finance)
ATS Medical Inc. received FDA clearance for a device used to repair heart valves, the company said Friday.

Gerald F. Masoudi Named FDA Chief Counsel Gerald F. Masoudi

Gerald F. Masoudi Named FDA Chief Counsel
Gerald F. Masoudi has been appointed as associate general counsel/chief counsel of the Food and Drug Division of the United States Department of Health and Human Services' Office of the General Counsel, which handles legal matters for the U.S. Food and Drug Administration.

C-flex? intraocular lens C-flex? is a plastic lens used to

C-flex? intraocular lens
C-flex? is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts... (Approved: 5/3/2007)

Private Selection Ice Cream Recalled From Ralphs and Food 4

Private Selection Ice Cream Recalled From Ralphs and Food 4 Less Stores in California (Sept. 20)
The ice cream is being recalled because it may contain eggs, which are not listed in the ingredient statement. People who have an allergy to eggs run the risk of serious or life-threatening reaction if they consume this product.

Bell's Fishery Issues Allergy Alert on Undeclared Egg, Soy and Milk products in Bell's Whitefish Pate (Oct. 25)
The recalled Bell's Whitefish Pate was sold in Michigan at Bell's Fishery located at 229 S Huron St. in Mackinac City, and Biindigen Gas Station located at 2169 US 31 North, in Petoskey. The product comes in an 8 ounce or 16 ounce plastic container marked with lot #100607, expiration date 10-20-07, or lot # 100807, expiration date 10-28-07.