17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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Tags: Anemia, Chronic Kidney Disease, Disease Patients, Drug Application, Fda, Ferumoxytol, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Iron Anemia, Iron Deficiency, Iron Deficiency Anemia, Nasdaq, Nda, Pharmaceuticals Inc, Prescription Drug, Response Letter, Target Action

14 Nov 08 TheraQuest’s IND For Abuse Deterrent Strong Opioid (TQ-1015) Accepted By FDA

TheraQuest Biosciences, Inc. a development stage pain management company announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (”IND”) application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using SECUREL(R), TheraQuest’s proprietary abuse deterrent technology.
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Tags: Company Announced That, Development Stage, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Management Company, Opioid, Pain Management, Technology, Theraquest

10 Nov 08 FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration’s ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals.
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Tags: Active Pharmaceutical Ingredient, Api, Celsus, Cincinnati Ohio, Fda, Food And Drug, Food And Drug Administration, Heparin, Laboratories Inc, Lithium, Sodium

09 Nov 08 Next Generation, Radically Smaller Aortic Aneurysm Endograft And Delivery System From Cook Medical Submitted For Clinical Trial Approval

Cook Medical, the world leader in endovascular repair of aortic disease, has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration for its new Zenith Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft.
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Tags: Aaa, Abdominal Aneurysm, Abdominal Aortic Aneurysm, Clinical Trial, Cook Medical, Delivery System, Endograft, Endovascular Graft, Food And Drug, Food And Drug Administration, Investigational Device Exemption, Low Profile, Next Generation, World Leader, Zenith

06 Nov 08 Aurora(R) 1.5Tesla Dedicated Breast MRI System Has Received 501(k) Clearance From FDA

Aurora Imaging Technology Inc. is proud to announce that the Aurora® 1.5Tesla Dedicated Breast MRI System has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for AuroraSPECTROSCOPY™, the company’s breast magnetic resonance (MR) spectroscopy package. The availability of AuroraSPECTROSCOPY will provide Aurora Breast MRI the capability to perform in vivo breast MR spectroscopy (MRS) and MR spectroscopic imaging (MRSI).
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Tags: Aurora, Breast Magnetic Resonance, Breast Mri, Capability, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Imaging Technology Inc, Mr Spectroscopy, Mri System, Spectroscopic Imaging, Vivo

05 Nov 08 Experts say FDA findings on compound mislead

A panel of experts accused the Food and Drug Administration of creating “a false sense of security” with its assessment that a compound used to make food and beverage containers poses no immediate health risks.

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Tags: Beverage Containers, False Sense Of Security, Fda, Food And Beverage, Food And Drug, Food And Drug Administration, Health Risks, Sense Of Security

05 Nov 08 FDA Faulted for Stance on Chemical in Plastics (HealthDay)

HealthDay - FRIDAY, Oct. 31 (HealthDay News) — A U.S. Food and Drug
Administration advisory panel agreed Friday that the agency had erred in
August when it said that a chemical widely used in baby bottles and other
plastic packaging for foods and beverages posed no health risks.
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Tags: Advisory Panel, Baby Bottles, Fda, Food And Drug, Food And Drug Administration, Foods And Beverages, Health Risks, Healthday News, Oct 31, Plastic Packaging, Plastics

05 Nov 08 Hi-Tech Pharmacal Receives Final Approval For Dorzolamide And Timolol Ophthalmic Solution

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the U.S. Food and Drug Administration (FDA) granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt® which had sales of $342 million for the 12 months ended June 2008 according to IMS.
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Tags: 12 Months, Abbreviated New Drug Application, Cosopt, Dorzolamide, Fda, Fda Approval, Final Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Hi Tech Pharmacal, Hi Tech Pharmacal Co, Hi Tech Pharmacal Co Inc, Hitk, Ims, Merck, Months Ended June, Nasdaq, Ophthalmic Solution, Timolol

05 Nov 08 Orphan Drug Designation For ALD-10, Novel Stem Cell Therapy For Patients With Metabolic Disorders Undergoing Umbilical Cord Blood Transplantation

Aldagen, Inc. today announced that it has received orphan drug designation for ALD-101 from the U.S. Food and Drug Administration (FDA). The designation was granted for the use of ALD-101 to improve patient outcomes by decreasing time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation.
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Tags: Ald, Aldagen, Cord Blood Transplantation, Engraftment, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Metabolic Disorders, Novel, Orphan Drug Designation, Patient Outcomes, Stem Cell Therapy, Today Announced That, Umbilical Cord

05 Nov 08 FDA Accepts Arana’s Anti-inflammatory IND

Biotechnology company Arana Therapeutics Limited (ASX: AAH) announced that lead anti-inflammatory compound, ART621 has successfully passed review of its rheumatoid arthritis Investigational New Drug (IND) application by the US Food and Drug Administration (FDA). IND status indicates regulatory approval to conduct clinical trials in humans in the United States and represents the first review of ART621 data by a major Regulatory Authority.
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Tags: Anti Inflammatory, Arana, Arthritis, Asx, Biotechnology Company, Clinical Trials, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Lead, Limited, Regulatory Approval, Regulatory Authority, Rheumatoid Arthritis, United States, Us Food And Drug Administration

05 Nov 08 Supraventricular Tachycardia In Cardiac Patients - FDA Approval Of Adenosine Injection USP, 3 Mg/mL

Akorn, Inc. (NASDAQ: AKRX) today announced that the U.S. Food and Drug Administration has granted approval for Akorn’s Abbreviated New Drug Application (ANDA) for Adenosine Injection USP, 3 mg/mL. Adenosine Injection is indicated for supraventricular tachycardia in cardiac patients. Annual sales for Adenosine Injection were approximately $22 million in 2007, according to IMS sales data. Arthur S.
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Tags: Abbreviated New Drug Application, Akorn Inc, Arthur, Cardiac Patients, Fda, Fda Approval, Food And Drug, Food And Drug Administration, Ims, Ml, Nasdaq, Supraventricular Tachycardia, Usp

05 Nov 08 Application To FDA For Avastin In The Most Aggressive Form Of Brain Cancer

Genentech, Inc. (NYSE:DNA) today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) as a therapy for people with previously treated glioblastoma.
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Tags: Avastin, Bevacizumab, Biologics License Application, Brain Cancer, Dna, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Genentech Inc, Nyse, People, Sbla, Today Announced That

04 Nov 08 Akorn-Strides, LLC Announces FDA Approval For Pamidronate Disodium Injection, 3 Mg/mL And 9 Mg/mL

Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application (ANDA) for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2004 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR) (BSE: 532531).
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Tags: Abbreviated New Drug Application, Akorn Inc, Akrx, Bse, Fda, Fda Approval, Food And Drug, Food And Drug Administration, Joint Venture, Limited, Llc, Ml Vials, Nasdaq, Pamidronate, Strides

20 Oct 08 FDA Approvaes Powerlink XL System For The Treatment Of Abdominal Aortic Aneurysms In Patients With Large Aortic Necks

Endologix, Inc. (Nasdaq:ELGX) today announced U.S. Food and Drug Administration (FDA) approval of the PMA supplement for its Powerlink XL® System, which includes new suprarenal stent grafts as well as the new Powerlink XL stent graft. This approval substantially broadens the Company’s treatment indications for the Powerlink System, which is used in the minimally invasive treatment of abdominal aortic aneurysms (AAA).
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Tags: Aaa, Abdominal Aortic Aneurysms, Elgx, Endologix Inc, Fda, Fda Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Grafts, Invasive Treatment, Nasdaq, Pma Supplement, Powerlink, Stent Graft, Treatment Of Abdominal Aortic Aneurysms, Xl System

18 Oct 08 Berlin Heart’s EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

Berlin Heart Inc. announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the Investigational Plan for the IDE study of the device.
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Tags: Berlin Heart, Clinical Trial, Excor, Fda, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Ide, Investigational Device Exemption, Investigational Plan, States Of America, Unconditional Approval, United States Of America, Ventricular Assist Device

17 Oct 08 FDA Approves Astepro - Nasal Antihistamine In The Treatment Of Rhinitis

The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S. Astepro is now approved for treatment of seasonal allergic rhinitis.
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Tags: Allergic Rhinitis, Antihistamine, Astelin, Astelin Nasal Spray, Fda, Fda Approved, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Seasonal Allergic Rhinitis

16 Oct 08 Perennial Allergic Rhinitis And Chronic Urticaria In Children - FDA Approves Cetirizine Hydrochloride Oral Solution

Cypress Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted final approval of the company’s abbreviated new drug application (ANDA) for the prescription and over-the-counter versions of Cetirizine Hydrochloride Oral Solution, 1 mg/1 mL. Cypress’ Cetirizine HCl Oral Solution is the AA-rated generic equivalent to McNeil Consumer Healthcare’s Zyrtec® Oral Solution.
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Tags: Aa, Abbreviated New Drug Application, Allergic Rhinitis, Cetirizine, Chronic Urticaria, Cypress, Fda, Final Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Generic Equivalent, Hydrochloride, Mcneil Consumer Healthcare, Ml, Oral Solution, Perennial Allergic Rhinitis, Pharmaceutical Inc, Urticaria, Zyrtec

16 Oct 08 FDA Grants Orphan Drug Status To Reata’s RTA 402 For Treatment Of Pancreatic Cancer

Reata Pharmaceuticals, Inc. announces that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease. “Pancreatic cancer is a devastating disease with few effective therapies,” said Warren Huff, CEO of Reata.
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Tags: Ceo, Chronic Kidney Disease, Fda, Fda Grants, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Huff, Kidney Cancer, Orphan Drug Designation, Orphan Drug Status, Pharmaceuticals Inc, Phase 1, Phase 2, Rta, Treatment Of Pancreatic Cancer

16 Oct 08 St. Jude Medical Announces U.S. And European Approval Of Angio-Seal Evolution Vascular Closure Device

St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approval of the Angio-Seal™ Evolution™ Vascular Closure Device. The approval and global launch was announced at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.
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Tags: Angio Seal, Ce Mark, Closure, European Approval, Evolution, Fda, Fda Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Launch, Nyse, St Jude Medical, St Jude Medical Inc, Stj, Washington D C

14 Oct 08 FDA Approves Bayer HealthCare’s Kogenate(R) FS Treatment For Routine Prophylaxis In Children With Hemophilia A

Bayer HealthCare LLC announced that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage.
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Tags: Bayer Healthcare Llc, Fda, Fda Approved, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Hemophilia, Kogenate, Prophylaxis, Risk