FDA approves REMS for Gabitril - MPR
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FDA approves REMS for Gabitril - MPR
empr.com —
View full resource at empr.com
Tags: Drug, FDA, Cephalon, News
Most Recently Shared on October 15, 2010 at 2:06 pm By:
MPR News: FDA approves REMS for Gabitril: The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) fo... http://bit.ly/bz7JDu
FDA Announces Classwide REMS for Specific Fentanyl Medications -- AAFP News Now -- American Academy of Family Physicians
aafp.org — “The FDA recently announced it has approved a single shared-system risk evaluation and mitigation strategy, or REMS, for the entire class of transmucosal immediate-release fentanyl, or TIRF, prescription medications. The so-called TIRF REMS Access program, which would supersede the individual TIRF medication REMS programs currently in place, is scheduled to go live in March.” View full resource at aafp.org
Most Recently Shared on January 9, 2012 at 11:33 pm By:
FDA Announces Classwide REMS for Specific Fentanyl Medications http://t.co/58RUr6dL
FDA To Approve Shared System REMS For TIRF Products
medicalnewstoday.com — “The U.S. Food and Drug Administration approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared syste” View full resource at medicalnewstoday.com
Most Recently Shared on January 3, 2012 at 9:05 am By:
MNT Drug Approvals Health News
FDA To Approve Shared System REMS For TIRF Products http://t.co/HLAxWPHJ #regulatory
ONSOLIS To Benefit From Approval Of Class-Wide REMS For All Transmucosal Fentanyl Products
medicalnewstoday.com — “BioDelivery Sciences International, Inc. (Nasdaq: BDSI) responded to the approval and announcement by the U.S. Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS)” View full resource at medicalnewstoday.com
Most Recently Shared on January 3, 2012 at 9:05 am By:
MNT Drug Approvals Health News
ONSOLIS To Benefit From Approval Of Class-Wide REMS For All Transmucosal Fentanyl Products http://t.co/YsvDfdto #regulatory
ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program
news-medical.net — “ProStrakan, Inc., a subsidiary of Kyowa Hakko Kirin Co. Ltd., and an international specialty pharmaceutical company, today announces that the U.S. Food and Drug Administration has approved the TIRF (Transmucosal Immediate Release Fentanyl) REMS Access program.” View full resource at news-medical.net
Most Recently Shared on December 31, 2011 at 9:46 am By:
Asthma News: ProStrakan announces FDA approval for Transmucosal Immediate Release Fentanyl REMS Access program: ... http://t.co/nPPSI5Gr
Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta - FDA
medicalnewstoday.com — “The FDA approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag). According to an FDA-initiated review of the current infor” View full resource at medicalnewstoday.com
Most Recently Shared on December 8, 2011 at 11:05 pm By:
Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta - FDA http://t.co/OGIydEDM #healthnews
FDA approves changes to REMS for Nplate and Promacta
news-medical.net — “The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration.” View full resource at news-medical.net
Most Recently Shared on December 7, 2011 at 3:03 pm By:
News-Medical.Net Health News and Oncology
Oncology News: FDA approves changes to REMS for Nplate and Promacta: The approval of changes to the Risk Evaluat... http://t.co/vByUoI1r
FDA approves REMS for Fentora, Actiq | Oral Cancer News
oralcancernews.org — “FDA approves REMS for Fentora, Actiq | Oral Cancer News” View full resource at oralcancernews.org
Most Recently Shared on July 25, 2011 at 10:44 am By:
Human Genome Approval Could Be A Relief - Matthew Herper - The Medicine Show - Forbes
blogs.forbes.com — “Tonight, the Food and Drug Administration approved Benlysta, the first treatment for lupus, a deadly autoimmune disease, in 56 years. The approval comes without several hurdles that had worried some investors in the drug's developer, Human Genome Sciences. An FDA spokeswoman confirms the drug will not carry a severe boxed warning [...]” View full resource at blogs.forbes.com
Most Recently Shared on March 10, 2011 at 4:05 am By:
Drugs and Devices OW OW Health
Human Genome Approval Could Be A Relief: The lack of a black box and a REMS could be a relief to some investors. http://bit.ly/ePww8s #drug
FDA Approves Revised Alphanate Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD - Drugs.com MedNews
drugs.com — “Alphanate is the first plasma-derived blood clotting factor to include labeling statements on manufacturing processes that provide a reasonable assurance of rem” View full resource at drugs.com
Most Recently Shared on March 7, 2011 at 3:14 pm By:
Drugs and Devices OW OW Health
FDA Approves Revised Alphanate Labeling to Include Reduced Infectivity of an Experimental Model Agent for ... http://bit.ly/hK4Wuu #drug
REMS approved for Nuvigil and Provigil - ONA
oncologynurseadvisor.com — “Cephalon announced that the FDA has approved Risk Evaluation and Mitigation Strategies (REMS) for its medications Nuvigil (armodafinil tablets) and Provigil (modafinil tablets).” View full resource at oncologynurseadvisor.com
Most Recently Shared on October 25, 2010 at 3:07 pm By:
OncologyNurseAdvisor Nursing, Medical Education, Medical Publisher, and Oncology
REMS approved for Nuvigil and Provigil http://goo.gl/fb/vJcSS
FDA approves Cephalon's REMS for GABITRIL
news-medical.net — “Cephalon, Inc. today announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA). The GABITRIL REMS consists of a Medication Guide to inform patients about the potential risks associated with the use of GABITRIL.” View full resource at news-medical.net
Most Recently Shared on October 15, 2010 at 9:13 am By:
Epilepsy News: FDA approves Cephalon's REMS for GABITRIL: Cephalon, Inc. today announced that a Risk Evaluation an... http://bit.ly/c5l1ZP
Cephalon Gabitril REMS gets FDA approval - Pharmaceutical Business Review
packaging.pharmaceutical-business-review.com — “Cephalon said that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication Gabitril (tiagabine hydrochloride) has been appro” View full resource at packaging.pharmaceutical-business-review.com
Most Recently Shared on October 15, 2010 at 6:49 am By:
Cephalon Gabitril REMS gets FDA approval http://goo.gl/bMIE #pharmaceutical #news
FDA approves Risk Evaluation and Mitigation Strategy (REMS) for Qualaquin - ONA
oncologynurseadvisor.com — “The FDA has approved a Risk Evaluation and Mitigation Strategy (REMS) for Qualaquin (quinine sulfate capsules, from AR Scientific) to warn against --off-label-- uses.” View full resource at oncologynurseadvisor.com
Most Recently Shared on July 9, 2010 at 2:25 pm By:
OncologyNurseAdvisor Nursing, Medical Education, Medical Publisher, and Oncology
FDA approves Risk Evaluation and Mitigation Strategy (REMS) for Qualaquin http://goo.gl/fb/QeJUc
FDA makes REMS a drug approval staple - FiercePharma Manufacturing
fiercepharmamanufacturing.com — “St. Louis-based law firm Bryan Cave expects the FDA to step up its risk evaluation and mitigation strategy activities in the coming year. "Stakeholders have expressed that they would like PDUFA V... Read more...” View full resource at fiercepharmamanufacturing.com
Most Recently Shared on May 13, 2010 at 2:05 pm By:
FDA makes REMS a drug approval staple. http://bit.ly/afMvIb
REMS, FDAAA restrain annual drug-approval rate - FiercePharma Manufacturing
fiercepharmamanufacturing.com — “The FDA's greater authority and the increased responsibilities bestowed by the FDA Amendments Act in 2007--including its ability to require REMS programs--have conspired to keep drug-approval rates Read more...” View full resource at fiercepharmamanufacturing.com
Most Recently Shared on April 7, 2010 at 6:02 pm By:
Report: The FDA Amendments Act has depressed drug approval rates. http://is.gd/biSgg
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