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FDA News
March 20, 2015
FDA approves first biosimilar product Zarxio: Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s
Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications
as Neupogen, and can be prescribed by a health care professional for:
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patients with cancer receiving myelosuppressive chemotherapy;
patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
patients with cancer undergoing bone marrow transplantation;
patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
Patients with severe chronic neutropenia.
With the approval of the first biologic
Biosimilars: More Treatment Options Are on the Way:
approved under the new biosimilar standards, FDA points the way toward the future of new
competition in a dynamic field of innovation.
FDA seeks input on product-specific recommendations to assist and facilitate generic drug
development: FDA has published 60 product-specific recommendations describing the Agency’s
current thinking and expectations on how to develop generic drug products therapeutically equivalent
to specific reference-listed drugs.
FDA's Commissioner's Fellowship Program now accepting applications from March 16-April 24, 2015!:
FDA invites outstanding health care professionals, scientists, and engineers to apply to its two-year
Fellowship Program, where they will receive regulatory science training and the chance to conduct
cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA
senior scientist.;
Testosterone Products: Drug Safety Communication: FDA Cautions About Using Testosterone
Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased
Risk of Heart Attack And Stroke
Announcing the 2015 REdl: Generic Drugs Forum:
You are invited to FDA’s Regulatory Education
for Industry (REdI): Generic Drugs Forum which takes our previous GDUFA and You conference to a new
level by expanding our content to other regulatory aspects that concern the generic drug industry.
April 22-23, 2015
The Sheraton Silver Spring Hotel
Silver Spring, MD
This two-day conference offers you the opportunity to interact with FDA subject matter experts as we
discuss various topics along the dynamic continuum of the generic drug approval process. This forum
will be delivered in a hybrid format (you can attend virtually or in person).
This Event is FREE. However, advance registration is required.
LTCPharmacy.net
FDA Web Page Updates
The FDA Medication Guides Page: FDA Medication Guides page has been updated to include;
• Lynparza (olaparib) capsules
• BELSOMRA suvorexant Tablets C-IV
• OPDIVO (nivolumab) injection
Drug Information Update- New FDA Drug Info Rounds Video on NDC Directory
Warning Letters:
FDA has updated its Warning Letters page.
Approved Risk Evaluation and Mitigation Strategies (REMS):
• FARYDAK (panobinostat)
• REVLIMID® (lenalidomide)
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FDA Drug Shortages:
Updated
The FDA Drug Shortage page has been updated
Drug Information Update - FDA launches drug shortages mobile app
FDA Publishes Updated Orange Book: The latest version of the Approved Drug Products with
Therapeutic Equivalence Evaluations (Orange Book) is now available.
FDA "CDRH Learn" Website Updated: FDA's Center for Devices and Radiological Health's (CDRH’s)
innovative multi-media industry education website, “CDRH Learn”, has recently been updated to better
meet your regulatory educational needs.
Drug Approvals
• FDA approves new antifungal drug Cresemba
• FDA approves Cholbam to treat rare bile acid synthesis disorders
• Drug Information Update - FDA approves new antibacterial drug Avycaz