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 The leading web portal for pharmacy resources, news, education and careers March 31, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 31, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 54     Next >>     Go To Page:

3/31/15 - Antares Pharma Announces FDA Approval of TEV-TROPIN 10 mg Needle-Free Injector
Antares Pharma, Inc. today announced that Ferring Pharmaceuticals Inc. has received U.S. Food and Drug Administration approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON? for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet?. Ferring a
3/31/15 - Antares Pharma Announces FDA Approval of TEV-TROPIN(R) 10 mg (Human Growth Hormone) Needle-Free Injector
Antares Pharma, Inc. today announced that Ferring Pharmaceuticals Inc. has received U.S. Food and Drug Administration approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON? for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet?. Ferring
3/31/15 - ANTARES PHARMA, INC. FILES (8-K) Disclosing Regulation FD Disclosure, Financial Statements and Exhibits
On March 31, 2015, Antares Pharma, Inc. issued a press release announcing that Ferring Pharmaceuticals Inc. has received U.S. Food and Drug Administration approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON? for injection, and the needle-free delivery system to be marketed
3/31/15 - FDA Approves Investigational Study for New Smaller SynCardia Total Artificial Heart
The 50 cc heart is the smaller version of the 70 cc SynCardia Heart, which is FDA, Health Canada and CE mark approved. March 31, 2015/ 3 BL Media/- SynCardia Systems, Inc. has received FDA approval to conduct an Investigational Device Exemption clinical study on the effective use of its 50 cc SynCardia temporary Total Artificial Heart. The FDA appr
3/31/15 - Ferring Pharmaceuticals Receives FDA Approval for Growth Hormone Name Change, Acquires ZOMACTON? [somatropin (rDNA origin)] for Injection and Needle-Free Device in the U.S.
PARSIPPANY, N.J., March 31, 2015/ PRNewswire-USNewswire/ Ferring Pharmaceuticals Inc. today announced U.S. Food and Drug Administration approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON? for injection, and its needle-free delivery system to be marketed in the U.S. as ZO
3/31/15 - First Patient Enrolled in Cerus' TRUE Study With the American Red Cross to Address Chikungunya and Dengue Blood Safety Risks With Pathogen Reduced...
First Patient Enrolled in Cerus' TRUE Study With the American Red Cross to Address Chikungunya and Dengue Blood Safety Risks With Pathogen Reduced Platelets. The American Red Cross is producing INTERCEPT platelet components for the study, which is being conducted in Puerto Rico. While the INTERCEPT Blood System received FDA approval in December 201
3/31/15 - Medtronic CoreValve System Receives FDA Approval for Transcatheter Valve-In-Valve Procedures
First TAVR Device Indicated for Replacement of Failed Surgical Heart Valves Expands Patient Population That Can Benefit from Minimally Invasive Procedure. DUBLIN Medtronic plc today announced the U.S. Food and Drug Administration approval of the CoreValve System for valve-in-valve procedures in patients whose surgical aortic heart valves have...
3/31/15 - Mylan Launches Generic Exforge Tablets
POTTERS BAR, England and PITTSBURGH, March 31, 2015/ PRNewswire/ Mylan N.V. today announced the U.S. launch of Amlodipine and Valsartan Tablets, 5 mg/160 mg, 5 mg/320 mg, 10 mg/160 mg, 10 mg/320 mg, which is the generic version of Novartis' Exforge Tablets. Mylan received final approval from the U.S. Food and Drug Administration for its Abbrev
3/31/15 - NovaBay Pharmaceuticals Posts 2014 4Q and Full Year Financial Results and Offers Business Update [Health & Beauty Close - Up]
-Announced partner China Pioneer Pharma's launch of NeutroPhase Skin and Wound Cleanser in China beginning March 1. -Received regulatory clearance for NovaBay's NeutroPhase from Taiwan's Food and Drug Administration with anticipated product launch in Taiwan in the first half of 2015 by China Pioneer Pharma. -Biopharm Group to market NeutroPhase in
3/31/15 - Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload
Release date- 30032015- Basel,- Novartis announced today that the US Food and Drug Administration has approved JadenuTM tablets, a new oral formulation of Exjade tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-depende
3/31/15 - Novartis Says FDA Approves Jadenu Tablets
BASEL- Novartis announced that the US Food and Drug Administration has approved Jadenu tablets, a new oral formulation of Exjade tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes or NTDT
3/30/15 - AstraZeneca Says FDA Approves New Administration Option For BRILINTA
LONDON- AstraZeneca PLC announced the US FDA has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. The company said, unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube. Shares in AstraZe
3/30/15 - AstraZeneca: FDA Approves New Administration Option For BRILINTA
LONDON- AstraZeneca announced the US FDA has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. The company said, unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube. BRILINTA is an oral..
3/30/15 - Boston Scientific announces FDA and CE Mark Approval Of The EMBLEM? S-ICD System
By a News Reporter-Staff News Editor at Biotech Business Week Boston Scientific Corporation has received FDA and CE Mark approval of the EMBLEM? Subcutaneous Implantable Defibrillator System. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent
3/30/15 - Boston Scientific Receives FDA Approval for WATCHMAN? Left Atrial Appendage Closure Device
By a News Reporter-Staff News Editor at Biotech Business Week Boston Scientific Corporation has received U.S. Food and Drug Administration approval for the WATCHMAN Left Atrial Appendage Closure Device. "The WATCHMAN Device is an important step forward in stroke management for patients with AF," said Vivek Reddy, M.D., Director of the Cardiac Ar
3/30/15 - BRILINTA Receives US FDA Approval for New Administration Option
AstraZeneca today announced that the US Food and Drug Administration has approved a new administration option for acute coronary syndrome patients who are unable to swallow BRILINTA 90 mg tablets whole. Unlike other P2Y12 inhibitors, BRILINTA has FDA approval to be crushed and administered in water by swallowing or via nasogastric tube.
3/30/15 - CASI Pharmaceuticals Receives Approval From CFDA For Phase 2 Clinical Trial In China With ENMD-2076 For Ovarian Clear Cell Carcinoma
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration has approved the Company's application.
3/30/15 - CHOLBAM cholic acid Now Approved In The U.S. For Patients With Bile Acid Synthesis Disorders
By a News Reporter-Staff News Editor at Pharma Business Week Asklepion Pharmaceuticals, LLC. announced that the U.S. Food and Drug Administration approved CHOLBAM? as a once-daily treatment for cholic acid deficiency in bile acid synthesis disorders due to single enzyme defects. CHOLBAM is the first medication approved by the FDA to turn off a.
3/30/15 - Genzyme's Cerdelga (eliglustat) Capsules Approved in Japan
Genzyme, a Sanofi company, announced today that the Ministry of Health, Labor and Welfare has granted marketing approval for Cerdelga , the only oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. Cerdelga was approved by the U.S. Food and Drug Administration in August 2014, the European Commission in January 2015, and
3/30/15 - GNW-News: Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload (english)
Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Novartis International AG/ Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Basel, March 30, 2015- Novartis announced today that the US Food and Drug...
3/30/15 - Just Approved By FDA, New Ground Breaking Procedure for Heart Rhythm Patients
By a News Reporter-Staff News Editor at Pharma Business Week The Arizona Heart Rhythm Center will be the only medical facility in Arizona with access to a new device developed to lower the risk of stroke in patients with an irregular heartbeat who require blood thinning medications. The device, called the Watchman Left Atrial Appendage Closure
3/30/15 - Kalorama: 23andMe FDA Approval Clears Way for More Sequencing-Based Tests
By a News Reporter-Staff News Editor at Biotech Business Week- Kalorama information suggests that the FDA approval of a rare gene test from Mountain View, Calif.- based personal genetics company 23 andMe will open the way for more genetic tests sold to consumers or prescribed by doctors that use next-generation sequencing technology. A Feb. 19 ap
3/30/15 - Novartis announces FDA approval for Jadenu? to simplify treatment administration for patients with chronic iron overload
Novartis announced today that the US Food and Drug Administration has approved Jadenu? tablets, a new oral formulation of Exjade tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes i
3/30/15 - Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload
Novartis International AG/ Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload. Processed and transmitted by NASDAQ OMX Corporate Solutions. *Jadenu, a new formulation of Exjade, is the only once-daily oral tablet for iron chelation* Jadenu, taken with or without food, simplifies
3/30/15 - Semler Announces FDA Clearance for Next Generation PAD Testing System
By a News Reporter-Staff News Editor at Pharma Business Week Semler Scientific, Inc., an emerging medical risk assessment company that develops, manufactures and markets patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases, announced receipt of 510 marketing clearance from the U.S. Food and Dru
Articles(s): 1 - 25 of 54     Next >>     Go To Page:


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