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What's New on the FDA Drugs Site
March 29, 2017
Spotlight on CDER Science: Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
FY 2015 - 2016: Regulatory Science Progress Report (PDF - 1.4MB)
Drugs@FDA Data Files (updated)
FDA Drug Shortages
Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
National Drug Code Directory
Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)
New and Generic Drug Approvals
March 28, 2017
Drug Name and
Application NumberActive IngredientDosage Form/ RouteSubmissionCompanySubmission ClassificationSubmission StatusAbacavir Sulfate; Lamivudine
ANDA #204990 Abacavir Sulfate;Lamivudine Tablet; Oral ORIG-1 Lupin Ltd Approved
Abacavir Sulfate; Lamivudine
ANDA #206151 Abacavir Sulfate; Lamivudine Tablet; Oral ORIG-1 Aurobindo Pharma Ltd Approved
Fosaprepitant Dimeglumine
ANDA #204845 Fosaprepitant Dimeglumine Unknown ORIG-1 Sagent Pharms Tentative Approval
Motofen
NDA #017744 Atropine Sulfate; Difenoxin Hydrochloride Tablet; Oral SUPPL-26 Sebela Ireland Ltd LABELING Approved
Motofen Half-Strength
NDA #017744 Atropine Sulfate; Difenoxin Hydrochloride Tablet; Oral SUPPL-26 Sebela Ireland Ltd LABELING Approved
03/29/2017 05:13 PM EDT
Envy Me is recalling LaBri’s Body Health Atomic, dietary supplement marketed for weight loss, sold in 60 capsule, plastic bottles. The recall includes all lot codes, manufacturing codes and expiration dates. The United States Food and Drug Administration has analyzed samples of La Bri’s Body Health Atomic and found it to contain the undeclared ingredient sibutramine.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.
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Job Announcement Number:
1700252ASDE
Location Name:
District of Columbia, District of Columbia
Department:
General Services Administration
Agency:
GSA, Office of Mission Assurance
Occupation Code:
0080
Pay Plan:
GS
Appointment Duration:
Permanent
Opening Date:
Wednesday, March 29, 2017
Closing Date:
Wednesday, April 12, 2017
Job Status:
Full-time
Salary:
$54,972.00 to $71,467.00 / Per Year
Pay Grade(s):
09 to 09
Who May Apply:
All United States citizens and nationals (residents of American Samoa and Swains Island).
Job Summary:
GSA has been repeatedly named as one of the ' Best Places to Work ' in the Federal Government'. LEARN MORE about why you should choose GSA.) This is a developmental position. The Security Specialist is responsible for functioning in a supportive role to a team of Security Specialists in the development of comprehensive agency wide security management policies and plans. Additionally, the incumbent provides technical assistance to ensure policies and plans are properly developed, coordinated, and implemented in relation to GSA's mission and functional roles and responsibilities, to include the physical, industrial, personnel and information security program areas. As a Security Specialist, you may also be required to assume alternate Emergency Operations Center (EOC) duty and/or augment the Department of Homeland Security's (DHS) Federal Emergency Management Agency (FEMA) Regional Response Coordination Center (RRCC) in the event of an emergency/disaster or Presidential Declaration. This position is located within US General Services Administration (GSA), Office of Mission Assurance (OMA) located in Washington, DC. This office is responsible for planning, developing, implementing, administering all physical, industrial, information security, and insider threat programs for the General Services Administration. GSA offers its employees a wide range of benefits including: Federal health insurance plans (choose from a wide range of plans); Life insurance coverage with several options to choose from; Leave policies to help you take care of your personal, recreational, and health care needs; Thrift Savings Plan (similar to a 401(k) plan); Flexible work schedules and telework; Transit and child care subsidies; and Training and development. At this time we are only filling one position; however additional vacancies may be filled from this announcement as needed. Additional vacancies may be filled through this announcement in this or other GSA organizations within the same commuting area. This vacancy is also being announced as Vacancy Announcement Number 1700251ASMP under Merit Promotion regulations. Please review that announcement to see if you are eligible for consideration under Merit Promotion Procedures. Note: You must apply separately for each announcement in order to be considered under both procedures.
1700252ASDE
Location Name:
District of Columbia, District of Columbia
Department:
General Services Administration
Agency:
GSA, Office of Mission Assurance
Occupation Code:
0080
Pay Plan:
GS
Appointment Duration:
Permanent
Opening Date:
Wednesday, March 29, 2017
Closing Date:
Wednesday, April 12, 2017
Job Status:
Full-time
Salary:
$54,972.00 to $71,467.00 / Per Year
Pay Grade(s):
09 to 09
Who May Apply:
All United States citizens and nationals (residents of American Samoa and Swains Island).
Job Summary:
GSA has been repeatedly named as one of the ' Best Places to Work ' in the Federal Government'. LEARN MORE about why you should choose GSA.) This is a developmental position. The Security Specialist is responsible for functioning in a supportive role to a team of Security Specialists in the development of comprehensive agency wide security management policies and plans. Additionally, the incumbent provides technical assistance to ensure policies and plans are properly developed, coordinated, and implemented in relation to GSA's mission and functional roles and responsibilities, to include the physical, industrial, personnel and information security program areas. As a Security Specialist, you may also be required to assume alternate Emergency Operations Center (EOC) duty and/or augment the Department of Homeland Security's (DHS) Federal Emergency Management Agency (FEMA) Regional Response Coordination Center (RRCC) in the event of an emergency/disaster or Presidential Declaration. This position is located within US General Services Administration (GSA), Office of Mission Assurance (OMA) located in Washington, DC. This office is responsible for planning, developing, implementing, administering all physical, industrial, information security, and insider threat programs for the General Services Administration. GSA offers its employees a wide range of benefits including: Federal health insurance plans (choose from a wide range of plans); Life insurance coverage with several options to choose from; Leave policies to help you take care of your personal, recreational, and health care needs; Thrift Savings Plan (similar to a 401(k) plan); Flexible work schedules and telework; Transit and child care subsidies; and Training and development. At this time we are only filling one position; however additional vacancies may be filled from this announcement as needed. Additional vacancies may be filled through this announcement in this or other GSA organizations within the same commuting area. This vacancy is also being announced as Vacancy Announcement Number 1700251ASMP under Merit Promotion regulations. Please review that announcement to see if you are eligible for consideration under Merit Promotion Procedures. Note: You must apply separately for each announcement in order to be considered under both procedures.
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