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TXT NDA Accepted for Sunovian ADHD Drug [111 Words] [ Price : $8.95]
FDA accepts for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention deficit hyperactivity disorder.
11/10/2017
 
 
TXT FDA Approves Dynavax BLA for Hepatitis B Vaccine [130 Words] [ Price : $8.95]
FDA approves a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older.
11/10/2017
 
 
TXT Lensar Astigmatism Management Feature Cleared [74 Words] [ Price : $8.95]
FDA clears a Lensar 510(k) for its IntelliAxis-L, the company’s latest astigmatism management feature to guide toric intraocular lens alignment in cataract surgery procedures.
11/10/2017
 
 
TXT FDA Clears Neusoft Medical New CT Scanner [98 Words] [ Price : $8.95]
FDA clears a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner.
11/10/2017
 
 
TXT Heron NDA for Nausea Drug Approved [1214 Words] [ Price : $8.95]
FDA approves a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicated in adults, in combination with other antiemetic agents, for preventing acute and delayed nausea and vomiting.
11/10/2017
 
 
TXT FDA Harmonizing MDR Adverse Event Coding with Other Regulators [309 Words] [ Price : $8.95]
As part of an adverse event harmonization effort, FDA says it is no longer adding new adverse event codes for Medical Device Reporting in response to device manufacturer requests.
11/10/2017
 
 
TXT Teligent ANDA for Betamethasone Dipropionate Approved [51 Words] [ Price : $8.95]
FDA has approved a Teligent ANDA for a generic copy of Promius Pharma’s Sernivo, indicated for treating mild-to-moderate plaque psoriasis.
11/10/2017
 
 
TXT FDA Hits Lupin with Warning on 2 Indian Facilities [372 Words] [ Price : $8.95]
FDA issues a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected earlier this year and investigators documented significant GMP violations.
11/09/2017
 
 
TXT Comments Sought on Condom Labeling Info Collection [71 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.”
11/09/2017
 
 
TXT Upcoming Blood Products Advisory Committee Meeting [120 Words] [ Price : $8.95]
Federal Register notice: FDA announces an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting.
11/09/2017
 
 
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