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CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY ) an implantable biological medical device and cardiovascular tissue processing company, today announced it has received CE mark approval for its BioFoam((R)) Surgical Matrix (BioFoam). The CE mark allows immediate, unrest...

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG

MORRISTOWN, N.J., Aug. 3 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration...

Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

ALLEGAN, Mich., Aug. 3 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO ; TASE) today announced that its partner Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA ) (previously Barr Laboratories Inc.) has received final approval from the U.S. Food and Drug Administration ...

PharmaForce Inc. Receives FDA Approval for First Generic of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP

COLUMBUS, Ohio, July 31 /PRNewswire/ -- PharmaForce, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP, a ...

Caldwell College Receives Approval to Launch First Ph.D. for Applied Behavior Analysis-Autism Treatment in New Jersey

ABA program will be Caldwell College's First Doctoral Program CALDWELL, N.J., July 31 /PRNewswire-USNewswire/ -- Caldwell College will launch the first Ph.D. program in New Jersey for Applied Behavior Analysis (ABA), a well developed scientific discipline that is best known for ...

Nfocus Neuromedical Announces European Approval for Novel Guiding Catheter at Society of NeuroInterventional Surgery

PALO ALTO, Calif., July 29 /PRNewswire/ -- Nfocus Neuromedical Inc. announced today at the 6th Annual Meeting of the Society of NeuroInterventional Surgery ( www.snisonline.org ) that Nfocus has earned a European CE Mark approval for its novel guiding catheter, the Echo(TM) Di...

Cell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone in Europe

SEATTLE, July 29 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it was notified by the European Medicines Agency ("EMEA") that pixantrone is eligible to be submitted for a Marketing Authorization Application ("MAA") through...

Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol

PITTSBURGH, July 20 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for ...

Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)

PITTSBURGH, July 16 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tab...

Bausch & Lomb Receives Approval of Crystalens HD in Quarter Diopter Steps

ALISO VIEJO, Calif., July 13 /PRNewswire/ -- Bausch & Lomb announced today that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD(TM) in quarter diopter steps in the United States. The Crystalens accommodating intraocular lens (IOL) ...

Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges

ALLEGAN, Mich., July 13 /PRNewswire-FirstCall/ -- The Perrigo Company (Nasdaq: PRGO ; TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex lozenge USP, 2 mg and 4 mg in cherry and cinn...

Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)

PARSIPPANY, N.J. and INDIANAPOLIS, July 10 /PRNewswire-FirstCall/ -- Daiichi Sankyo, Inc. and Eli Lilly and Company (NYSE: LLY ) today announced that the U.S. Food and Drug Administration (FDA) approved Effient(TM) (prasugrel) tablets for the reduction of thrombotic cardiovascular events (incl...

Watson Pharmaceuticals Receives FDA Approval for Fruit and Cinnamon Flavored Coated Nicotine Gums

MORRISTOWN, N.J., July 8 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leader in generic and specialty branded pharmaceuticals, today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration to ma...

China Medicine Receives Approval for a RMB 20 Million Loan

GUANGZHOU, China, July 8 /PRNewswire-Asia/ -- China Medicine Corporation (OTC Bulletin Board: CHME) ("China Medicine" or "the Company"), a leading distributor and developer of prescription and over-the-counter pharmaceuticals, traditional Chinese medicines ("TCM"), nutritional and dietary-supp...

AbbeyMoor Medical Receives FDA Approval for Design Improvements to The Spanner(TM) Prostatic Stent

PARKERS PRAIRIE, Minn., July 6 /PRNewswire/ -- AbbeyMoor Medical Inc., a developer and manufacturer of medical devices for the management and treatment of prostatic obstruction, announced today that it has received PMA approval from the US Food and Drug Administration (FDA) for design changes to...

Lilly Receives Fourth FDA Approval for ALIMTA(R) (pemetrexed for injection)

INDIANAPOLIS, July 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY ) announced today it received a fourth approval from the U.S. Food and Drug Administration (FDA) for ALIMTA(R) (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advan...

Nephros Receives 510k Approval for Dual Stage Ultrafilters

RIVER EDGE, N.J., July 2 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has received 510k approval from the U...

Hospira Receives FDA Approval for Azithromycin for Injection

LAKE FOREST, Ill., June 29 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP ), the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration (FDA) approval for a 500 mg vial of azithromycin for injection in the ADD-Vantage(R) System. ...

Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R)

MORRISTOWN, N.J., June 24 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbrev...

CorNova(R) Receives CE Mark Approval for Valecor Platinum(R) Coronary Stent System

Advanced Platinum Surface Maximizes Biocompatibility and Biostabilityin a Bare-Metal Stent BURLINGTON, Mass., June 23 /PRNewswire/ -- CorNova Inc. today announced that it has received CE mark approval for its Valecor Platinum Coronary Stent System. (Logo: http://www.newscom.com/...

Biomodels' Oral Mucositis Expertise Speeds FDA Approval for ActoGeniX's Phase 1b Trial of AGO13 in Cancer Patients

ActoGeniX taps Biomodels CRO expertise in $1 billion market for cancer support care to relieve side effects of cancer treatments WATERTOWN, Mass., June 22 /PRNewswire/ -- Biomodels LLC, a preclinical research organization specializing in cancer support care, today announced that its customize...

China Pharma Holdings, Inc. Announces SFDA Approval for Rosuvastatin Clinical Trials

HAIKOU CITY, China, June 22 /PRNewswire-Asia-FirstCall/ -- China Pharma Holdings, Inc. ("China Pharma") (OTC Bulletin Board: CPHI), which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that it has received official approval from China's State Fo...

Sinobiopharma Receives Trademark Approval and Authentication From Chinese Government For Its 'Tai' Drug Series

NANTONG CITY, China, June 18 /PRNewswire/ -- Sinobiopharma, Inc. ("Sinobiopharma" or, the "Company") (OTC Bulletin Board: SNBP) is pleased to announce today that it has received approval and authentication from the Trademark Bureau of China for its pre-surgical skeletal muscle relaxant Cisatracuri...

Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)

Product shipment has begun PITTSBURGH, June 17 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (AND...

Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules

NEWPORT, Ky., June 17 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain i...

Medifocus, Inc. receives Authorization Approval from Health Canada to launch its pivotal Phase III clinical study of focused microwave heating for treatment of breast cancer in Canada

VANCOUVER, June 9 /PRNewswire-FirstCall/ - Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has been granted the Investigational Testing Authorization (ITA) from Health Canada's Medical Device Bureau (MDB) for initiating Medifocus' pivotal trial with the Microfocus APA 1000 Breast Thermot...

Cardiatis Multilayer Aneurysm Repair System, MARS, Receives CE Mark Approval for Treating Peripheral Aneurysms

Cardiatis SA, today announced that its Multilayer Aneurysm Repair System (MARS) has received CE Mark approval for treating patients with peripheral aneurysms. Product rollout is underway. Brussels, Belgium (PRWEB) June 9, 2009 -- Cardiatis, SA announced today that it ha...

Avoid the Burn: First Sunscreen to Earn the Melanoma International Foundation Seal of Approval Expands Distribution Throughout Northern California

Specially formulated for sensitive skin and to block UVA and UVB rays, Sierra Summits now available at Raley's stores RENO, Nev., June 4 /PRNewswire/ -- Sunscreens are not created equal. As dermatology experts continue to emphasize the importance of broad spectrum protection that blocks UVA a...

XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration

MENLO PARK, Calif., June 4 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT ) today announced that the Company received conditional approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) authorizing it to begin its pivotal clinical pro...

China Sky One Medical, Inc. Obtains SFDA Approval for Diclofenac Sodium Eye Drops

HARBIN, China, June 2 /PRNewswire-Asia-FirstCall/ -- China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI ), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that it o...

Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)

LA JOLLA, Calif., June 2 /PRNewswire-FirstCall/ -- Cordex Pharma, Inc. (OTC Bulletin Board: CDXP) announced today that the U.S. Food and Drug Administration (FDA) has approved the design of pivotal, Phase 2b/3 clinical trials evaluating its lead product ATPace(TM) as an antiarrhytmic drug for the ...

Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis ('Pink Eye')

- Besivance Adds to Bausch & Lomb's Expanding Ocular Pharmaceuticals Portfolio and Offers New Therapeutic Option for a Wide Range of Ocular Bacterial Pathogens(1) - MADISON, N.J., May 29 /PRNewswire/ -- Bausch & Lomb, a world leader in eye health, today announced that the U.S. Food...

Transatlantic Regulatory Integration of Drug Approval Process Vital for the Global Pharmaceutical Industry, Notes Frost & Sullivan

LONDON, May 19 /PRNewswire/ -- Regulatory processes differ across continents, posing challenges to drug launches. There is a pressing need to integrate the regulatory environment of the European Union (EU) and the U.S. Diverse regulations impact drug launches as less price controlled markets witne...

FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder

RISPERDAL(R) CONSTA(R) is the First and Only Long-Acting Antipsychotic Therapy Available for Bipolar I Disorder TITUSVILLE, N.J., May 18 /PRNewswire/ -- Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved ...

XTENT, Inc. Announces Approval of Plan of Liquidation and Dissolution by Board of Directors and Filing of Proxy Materials With the SEC

MENLO PARK, Calif., May 15 /PRNewswire-FirstCall/ -- XTENT, Inc. ("XTENT" or the "Company") (Nasdaq: XTNT ) today announced that its Board of Directors has determined, after consideration of potential strategic alternatives, that it is in the best interests of the Company and its stockholders to...

IQAir HealthPro Plus Wins Parent Tested Parent Approved Seal of Approval Award

IQAir Recognized as the Most Effective Room Air Purifier in Parenting Products SANTA FE SPRINGS, Calif., May 15 /PRNewswire/ -- IQAir North America, Inc., the industry leader in the design and manufacture of superior air cleaning products, announced today the IQAir HealthPro Plus earned the...

P&G Response to FDA Approval of Prevacid OTC(R) 24HR

CINCINNATI, May 14 /PRNewswire/ -- In response to the FDA's approval of Prevacid OTC(R) 24HR, The Procter & Gamble Company issued the following statement: (Photo: http://www.newscom.com/cgi-bin/prnh//NY17325 ) "Prilosec OTC(R) is the #1 doctor and pharmacist recommended over-...

Video: Novartis Receives Approval From FDA to Market Prevacid(R) 24HR as First and Only OTC Proton Pump Inhibitor in Original Prescription Formulation

- This approval will provide greater convenience and broader access to an effective treatment option to the 50 million Americans(1) suffering from frequent heartburn - Once-daily, prescription-strength Prevacid(R) 24HR is the first OTC proton pump inhibitor approved for the treatment of freq...

Red Mango Receives 'AKA' Stamp of Approval From Ashley Koff, R.D., Underscoring Its Commitment to Good Health

LOS ANGELES, May 13 /PRNewswire/ -- Red Mango, the very popular and fastest-growing retailer of authentic nonfat frozen yogurt today announced it has received the "AKA" seal, a certification confirming that Red Mango's frozen yogurt products have been reviewed and approved as a high quality, delic...

AZOR(R) Receives FDA Approval as First-Line Treatment for High Blood Pressure

Fixed-dose combination offers a convenient option that may help patients reduce steps to reach their blood pressure goals while decreasing patient pill burden(1) PARSIPPANY, N.J., May 13 /PRNewswire/ -- Daiichi Sankyo, Inc. today announced that the United States Food and Drug Administration (...
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