April 2007 - FDA News

FDA Approvals - 3 Indian firms get FDA nod for sleep disorder drug

3 Indian firms get FDA nod for sleep disorder drug (rediff.com)
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi

Indian pharma firms corner chunk of US drug approvals (Business Standard India)
As the Indian pharmaceutical companies aggressively pursue research and development to capture the market for drugs going off-patent, a dozen companies led by Aurobindo Pharma, Wockhardt, Ranbaxy, Dr Reddy s Lab and Sun Pharma have bagged almost one-fourth of generic drug approvals in the US in the four-and-a-half month from December 2006.

Indian pharma majors cash in on off-patent drugs (rediff.com)
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.

FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated

FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated Olives
The olives are sold under the following brands: Borrelli, Bonta di Puglia, Cento, Corrado's, Dal Raccolto, Flora, Roland and Vantia, and have codes that start with the letter "G" and are followed by 3 or 4 digits. All sizes of cans, glass jars and pouches of Cerignola, Nocerella and Castelvetrano type olives are affected.

New implanted form of birth control available (Midland Reporter-Telegram) A

New implanted form of birth control available (Midland Reporter-Telegram)
A newly approved form of birth control, Implanon, is now available in the Permian Basin.

FDA to Hold Public Hearing on Medication Guide Program The

FDA to Hold Public Hearing on Medication Guide Program
The goals of the public hearing include assessing the effectiveness of Medication Guides in communicating the risks of certain drug and biological products to consumers and identifying Medication Guide distribution challenges and solutions.

INTROL? CF Panel I Control INTROL? CF Panel I Control

INTROL? CF Panel I Control
INTROL? CF Panel I Control is DNA quality control material that is used to monitor the performance of genetic tests used in the detection of variations in the gene called cystic fibrosis transmembrane conductance regulator (CFTR) in human blood specimens. (Approved: 9/18/2006)

Wilbur-Ellis Voluntarily Recalls Rice Protein Concentrate (April 18) Wilbur-Ellis noted

Wilbur-Ellis Voluntarily Recalls Rice Protein Concentrate (April 18)
Wilbur-Ellis noted that it obtained rice protein from a single source in China and shipped to a total of five U.S. pet-food manufacturers located in Utah, N.Y., Kansas and two in Missouri.

Natural Balance Pet Foods, Inc. Recalls Products in Response to American Nutrition Inc. Pet Food Recall (April 27)
Natural Balance Pet Foods is taking this voluntary action after learning the Food and Drug Administration (FDA) confirmed rice protein concentrate used by American Nutrition contained melamine, a substance not approved for use in food. These products are being recalled in addition to our previously recalled Venison and Brown Rice canned and bagged dog foods, Venison and Brown Rice dog treats, and Venison and Green Pea dry cat food.

FDA Approves Antibiotic Ointment for Children and Adults The Food

FDA Approves Antibiotic Ointment for Children and Adults
The Food and Drug Administration (FDA) approved Altabax (retapamulin ointment) for topical treatment of impetigo, a skin infection caused by bacteria.

FDA Approvals - Del. drug company develops HIV blocker (The News Journal) A

Del. drug company develops HIV blocker (The News Journal)
A small pharmaceutical company outside Wilmington has developed a promising new type of HIV drug that could make it a key player in the fight against the virus that causes AIDS.

New FDA Initiatives to Accelerate the Approval of Emerging Diagnostics and Drugs (Business Wire via Yahoo! Finance)
DUBLIN, Ireland----Research and Markets has announced the addition of Biomarkers and Related Tests for Molecular Diagnostics and Pharma/ Biotech R&D -- Companies Products and WW Market, 2004-2009 to their offering.

ArthroCare Receives FDA Clearance to Market Magnum(R) PI Knotless Implant System (Business Wire via Yahoo! Finance)
AUSTIN, Texas----ArthroCare Corp. announced today that it has received 510 clearance from the U.S. Food and Drug Administration to market its Magnum PI Knotless Implant System, which utilizes implants made of polyetheretherketone for the attachment of soft tissue to bone.

FDA rejects Merck's Vioxx successor (India Daily) The Food and

FDA rejects Merck's Vioxx successor (India Daily)
The Food and Drug Administration rejected Merck & Co.'s request to market a successor to its withdrawn arthritis drug Vioxx in the United States, the drugmaker said Friday. The move was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.

Transcript of Tele-News Conference Regarding FDA-USDA Update on Recall of Pet Foods Washington D.C. April 26, 2007 (USDA)
MODERATOR: Thank you. Welcome, ladies and gentlemen. I'm Julie Zawisza, assistant commissioner for Public Affairs with the Food and Drug Administration.

PFab LP stops drug production following US FDA warning (PharmaBiz)
The US Food and Drug Administration (FDA) announced the entry of a consent decree of permanent injunction against PharmaFab Inc., its subsidiary, PFab LP, and two company officials, Mark Tengler, PharmaFab's president, and Russ McMahen, PFab's vice president of scientific affairs, to stop the illegal manufacture and distribution of prescription and over-the-counter drug products.

FDA Approvals - Merck, Schering, Buoyed by Medicare, May Lead Stocks (Update1) (Bloomberg.com)

Merck, Schering, Buoyed by Medicare, May Lead Stocks (Update1) (Bloomberg.com)
April 27 (Bloomberg) -- Pharmaceutical stocks are headed for their biggest annual gain since 2000 after a new U.S. drug insurance program and industrywide job cuts helped profits beat analysts' estimates.

A TOUGH YEAR, BUT NO REGRETS (Pioneer Press)
In the year since Boston Scientific bought the Arden Hills heart-device business of Guidant Corp., the company's stock price has fallen by about 30 percent and device sales have dropped.

3 Indian firms get FDA nod for sleep disorder drug (rediff.com)
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi

FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated

FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated Olives
The olives are sold under the following brands: Borrelli, Bonta di Puglia, Cento, Corrado's, Dal Raccolto, Flora, Roland and Vantia, and have codes that start with the letter "G" and are followed by 3 or 4 digits. All sizes of cans, glass jars and pouches of Cerignola, Nocerella and Castelvetrano type olives are affected.

FDA Approvals - Pharmacyclics Needs a Fair Shake (TheStreet.com) The FDA's handling of

Pharmacyclics Needs a Fair Shake (TheStreet.com)
The FDA's handling of the company's cancer drug doesn't fit the Dendreon-driven environment.

Wockhardt gets US FDA nod for anti-hypertensive drug (PharmaBiz)
Wockhardt Ltd has received approval from the US FDA for marketing Lisinopril in the US market. Wockhardt Ltd has received approval from the US FDA for marketing Lisinopril in the US market.

New FDA Initiatives to Accelerate the Approval of Emerging Diagnostics and Drugs (Business Wire via Yahoo! Finance)
DUBLIN, Ireland----Research and Markets has announced the addition of Biomarkers and Related Tests for Molecular Diagnostics and Pharma/ Biotech R&D -- Companies Products and WW Market, 2004-2009 to their offering.

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices
The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.

FDA Announces Audio Broadcasts on Emerging Drug Safety Information The

FDA Announces Audio Broadcasts on Emerging Drug Safety Information
The broadcasts, commonly known as podcasts, can be transmitted to personal computers and personal audio players.

New implanted form of birth control available (Midland Reporter-Telegram) A

New implanted form of birth control available (Midland Reporter-Telegram)
A newly approved form of birth control, Implanon, is now available in the Permian Basin.

FDA, Pet Food Makers To Defend Recall Response (KXAN 36

FDA, Pet Food Makers To Defend Recall Response (KXAN 36 Austin)
The Food and Drug Administration and pet food makers must answer to lawmakers on Capitol Hill after dozens of animals either died or became ill. Both are defending their response to the recall as the FDA warns tainted food may still be on store shelves.

FDA Approves Cepheids Test For Infectious Bacteria (SeekingAlpha via Yahoo! Finance)
Sara Calabro submits: FDA signed off Thursday on a new test for identifying Methicillin-resistant Staphylococcus aureus [MSRA ], the leading cause of hospital-acquired infections. The Xpert MSRA test, made by Sunnyvale, CA-based Cepheid , runs on the companys GeneXpert System and delivers results in just over one hour.

FDA rejects Merck's Vioxx successor (India Daily)
The Food and Drug Administration rejected Merck & Co.'s request to market a successor to its withdrawn arthritis drug Vioxx in the United States, the drugmaker said Friday. The move was widely expected, after a panel of FDA advisers two weeks ago voted 20-1 against approving the drug, Arcoxia.

Prot g GPS? and Prot g RX Carotid Stent Systems The Prot g

Prot g GPS? and Prot g RX Carotid Stent Systems
The Prot g GPS? and Prot g RX Carotid Stent Systems are used to re-open stenotic (narrowed) regions of the carotid arteries in the neck which supply blood to the brain, and they consist of two components, the stent and the delivery system. (Approved: 1/24/2007)

Agriculture Department Warns Consumers of Tainted Raw Milk Sold by

Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Butler County Dairy (April 13)
The Department of Agriculture has suspended sales of raw milk at the dairy and is ensuring that corrective action is taken. Samples taken from the farm during routine testing on April 9 tested positive for Listeria on April 13.

Diamond Pet Food Withdraws Products in Response to American Nutrition Inc. Pet Food Recall (April 26)
Diamond Pet Foods is taking this voluntary action after learning the Food and Drug Administration (FDA) confirmed rice protein concentrate used by American Nutrition contained melamine, a substance not approved for use in food.

FDA Approvals - Wockhardt gets US FDA nod for anti-hypertensive drug (PharmaBiz) Wockhardt

Wockhardt gets US FDA nod for anti-hypertensive drug (PharmaBiz)
Wockhardt Ltd has received approval from the US FDA for marketing Lisinopril in the US market. Wockhardt Ltd has received approval from the US FDA for marketing Lisinopril in the US market.

New products boosts Ranbaxy's net by 79% in Q1 (PharmaBiz)
Ranbaxy Laboratories has achieved better performance during the first quarter ended March 2007. The company's net profit has taken a quantum jump of 79 per cent and reached at Rs 128.70 crore from Rs 71.80 crore in the corresponding period of last year.

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices
The products are illegal because they are not produced according to the required current good manufacturing practice (CGMP) and many also lack required FDA approval. The case was filed in the United States District Court for the Northern District of Texas.