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 The leading web portal for pharmacy resources, news, education and careers March 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 26, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 61     Next >>     Go To Page:

3/25/17 - Lupin gets approval in inhalation space [Syrian Arab News Agency]
It received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from US Food and Drug Administration to market a generic version of Novartis Pharmaceuticals` TOBI 300 mg/5 ml. Lupin has the fifth largest pipeline of ANDA filings pending approval with US FDA 134 product filings pending approval. Cumulative Filings with the US FD
3/25/17 - Pharma & Healthcare Newsletter March 20 to March 24, 2017 [India Infoline News Service]
This week, "The US Food and Drug Administration has added one more clause in its import alert given to the drug maker, Divi's Laboratories Limited." Pharma Major Lupin Limited announced today that it has received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from the United States Food and Drug Administration to market a ge
3/24/17 - Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS design for uncompromised distance vision and presbyopia correction
Release date- 23032017- Basel- Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopi
3/24/17 - Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction [Kabulpress.org]
-The unique optical design of the ACTIVEFOCUS (TM) toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vision to potentially reduce dependence on glasses. Basel, March 23, 2017- Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration f
3/24/17 - FDA Approves First-ever Merkel Cell Carcinoma Drug, HTGM Riding High, FLXN Soars
THOUSAND OAKS- The European Commission has approved Amgen's AMGEVITA as a biosimilar to Humira for the treatment of certain inflammatory diseases. AMGEVITA is Amgen's first biosimilar to be approved by the European Commission. AMGEVITA was approved in the United States by the FDA last September.
3/24/17 - FDA Approves Increased Shelf Life and In-Use Storage at Room Temperature for Orfadin nitisinone
By a News Reporter-Staff News Editor at Drug Week Sobi, a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the lives of rare disease patients and their families, announced that the FDA approved a supplemental new drug application for Orfadin capsules in the U.S. The sNDA will allow
3/24/17 - FDA Approves Symproic (naldemedine) Once-Daily Tablets C-II for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
OSAKA, Japan& FLORHAM PARK, N.J.& STAMFORD, Conn. Shionogi Inc. and Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration approved Symproic 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation in adult patients with chron
3/24/17 - FDA Approves Treatment for Metastatic Merkel Cell Carcinoma
The US Food and Drug Administration has granted accelerated approval for Bavencio (avenulab), a treatment for a rare and aggressive form of skin cancer called metastatic Merkel cell carcinoma (MCC).
3/24/17 - FDA Grants Approval for BAVENCIO (avelumab)
Release date- 23032017- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announce that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use. Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US. Immuno-onco
3/24/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Release date- 23032017- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merke
3/24/17 - Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine
Release date- 23032017- WINNIPEG- Medicure Inc., a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug application for tetrabenazine tablets in the 12.5 mg and 25 mg st
3/24/17 - Merck KGaA : FDA Approves First Treatment For Rare Form Of Skin Cancer
NEW YORK CITY- Merck KgaA and Pfizer Inc. announced that the US Food and Drug Administration has approved BAVENCIO or avelumab Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma or mMCC. BAVENCIO will be co-commercialized by EMD Serono, the biopharmace
3/24/17 - Surgery Without the Knife: Mirabilis Medical Announces European Approval for Non-Invasive Uterine Fibroid Treatment
Mirabilis Medical, a Seattle- area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine fibroids throughout the European Union. The company simultaneously announced that it had received approval from the US Food and Drug Administrati
3/24/17 - Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Gel, 0.05%
By a News Reporter-Staff News Editor at Drug Week Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, announced it has received approval of the Company's abbreviated new drug application from the U.S. Food and Drug Administration of Clobetasol Propionate Gel, 0.05%. This is Teligent's second approval for 2017, and its th
3/23/17 - Alcon Announces FDA Approval For AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL
BASEL- Alcon, a division of Novartis, announced it has received approval from the US FDA for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopia at the same time. Alcon plans to commercialize the ACTIVEFOCUS toric
3/23/17 - Alcon Receives US FDA Approval for New AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with Activefocus Design for Uncompromised Distance Vision and...
BASEL, Switzerland, March 23 Novartis issued the following news release:. Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration for its AcrySof (R) IQ ReSTOR (R) +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS (TM) optical design for patients undergoing cataract sur
3/23/17 - Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction
Novartis International AG/ Alcon receives US FDA approval for new AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL with ACTIVEFOCUS (TM) design for uncompromised distance vision and presbyopia correction. *The unique optical design of the ACTIVEFOCUS toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vis
3/23/17 - Blood Bank: FDA audit clears whistleblower assertions in areas it regulates. But a key allegation was not addressed. [Alaska Dispatch News, Anchorage]
Bob Scanlon, CEO at Blood Bank of Alaska, said on Wednesday the detailed FDA audit and investigation cleared the blood bank of all allegations in areas the FDA oversees, including assertions the bank was overdrawing blood from donors. A copy of the FDA report was not available. The FDA does not specify a minimum inventory of blood BBA or other bloo
3/23/17 - FDA Approves First Treatment for Rare Form of Skin Cancer
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. This is the first FDA- approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. "While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved t
3/23/17 - FDA Approves NanoCoated Coronary Stent System Using DSG's eClinical Systems
CeloNova Biosciences, Inc., leveraging products and services provided by DSG, Inc., a leading eClinical software technology and data management global services firm, recently received US Food and Drug Administration approval of its first-in-class COBRA PzF? NanoCoated Coronary Stent System. There continues to be an unmet clinical need for pati
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab)
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announce that the US Food and Drug Administration has approved BAVENCIO (R) Injection 20 mg/mL, for intravenous use. Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US. Immuno-oncology is a top priori
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Pfizer, a pharmaceutical company, issued the following news release:. EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO (R) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric
3/23/17 - FDA Grants Approval for BAVENCIO (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
Merck and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. Continued approval for this indication may be contingent upon verification and description of cl
3/23/17 - Federal audit clears Blood Bank whistleblower assertions. But a key charge wasn't addressed. [Alaska Dispatch News, Anchorage]
Bob Scanlon, CEO at Blood Bank of Alaska, said on Wednesday the detailed FDA audit and investigation cleared the blood bank of all allegations in areas the FDA oversees, including assertions the bank was overdrawing blood from donors. A copy of the FDA report was not available. The FDA does not specify a minimum inventory of blood BBA or other bloo
3/23/17 - Further milestone for JUVORA dental disc: US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics
Release date- 22032017- A major innovation in dental prosthetics for comfort, durability and precision, the JUVORA dental disc, has received the US Food and Drug Administration 510 clearance for expanded indications. Following its successful CE mark approval in Europe and introduction onto the European dental market in 2012, the JUVORA dental disc
Articles(s): 1 - 25 of 61     Next >>     Go To Page:


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