FDA Confirms Paragraph IV Patent Litigation for Abacavir Sulfate, Dolutegravir and Lamivudine Tablets
Laurus Labs Generic Abacavir Sulfate Receives Approval in the U.S.
The Food and Drug Administration approved revisions to the TRIUMEQ (abacavir/dolutegravir/lamivudine) and DOVATO (dolutegravir/lamivudine) labels to include dosing in patients with creatinine clearance between 30 and 49 mL per min. Additionally drug interaction information for TRIUMEQ and riociguat were included in the label. A summary of the major labeling changes for TRIUMEQ is below. Similar changes were made to the DOVATO label.
The virus that causes COVID-19, SARS-CoV-2, cannot grow and spread through the body without the help of a protein called polymerase. Now researchers at Columbia University and the University of Wisconsin-Madison have identified several molecules that interfere with the polymerase reaction—and some of them are already FDA-approved to treat other viruses.
New Paragraph IV Certifications as of April 7, 2020
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure. In the US, Dovato is currently approved as a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.
GSK’s ViiV is poised to take a bite out of Gilead’s HIV empire, after its dual HIV regimen — Dovato — secured FDA approval on Monday, after the British drugmaker submitted its marketing application with a priority review voucher (PRV) last October, enabling a speedy response from the US regulator.
List of Paragraph IV Patent Certifications Feb-12, 2019
Aurobindo Pharma' Generic Abacavir Sulfate; Lamivudine Receives Approval in US
Aurobindo Pharma Generic Abacavir Sulfate; Lamivudine Receives Approval in US