Northera® (droxidopa) – First-time generic

Aurobindo, Ajanta, Sun, Zydus, Ascend/Alkem, Camber/Annora, and Novadoz/MSN launched AB-rated versions of Lundbeck’s Northera (droxidopa) capsules. February 19, 2021

Imfinzi® (durvalumab) – Indication withdrawal

AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the FDA. February 22, 2021

Libtayo® (cemiplimab-rwlc) – New indication

Regeneron announced the FDA approval of Libtayo (cemiplimab-rwlc), for the first-line treatment of patients with non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] ™ 50%) as determined by an FDA-approved test with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation or metastatic. February 22, 2021

Panzyga® (immune globulin intravenous, human – ifas) – New indication

Pfizer announced the FDA approval of Panzyga (immune globulin intravenous, human – ifas), for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. February 12, 2021