FDA reviewing Janssen’s CPR application—DOH

Published August 9, 2022, 10:07 PM

by Analou de Vera

In this file photo taken on May 07, 2021, Johnson & Johnson’s Janssen COVID-19 vaccines are seen on a table in Los Angeles, California. Frederic J. BROWN / AFP

The Food and Drug Administration (FDA) is currently reviewing the Certificate of Product Registration (CPR) application of vaccine maker Janssen for its Covid-19 vaccine.

This was reported by Department of Health (DOH) Officer-in-Charge Maria Rosario Vergeire on Tuesday, Aug. 9.

“According to the Food and Drug Administration, as of Aug. 9, isa pa lang po na manufacturer ang nakapag-apply ng CPR sa kanila and this would be Janssen from J&J,” said Vergeire in a press briefing.

“Right now, the FDA is currently reviewing and exercising the necessary work para sa application ng Janssen,” she added.

A CPR is being issued by the FDA to manufacturers to allow the market and selling of their products commercially.

To note, Janssen Biotech Inc. is owned by Johnson & Johnson.

On April 20, 2021, the FDA announced that it approved the Emergency Use Authorization application of Janssen for its single-shot Covid-19 vaccine.