Alembic – Recall of telmisartan

Alembic announced a voluntary, consumer-level recall of one lot of telmisartan 20 mg tablets because of a market complaint received which stated that one bottle labeled as 30-count telmisartan 20 mg tablets, incorrectly contained 30 tablets of telmisartan 40 mg tablets. March 24, 2021

Grifols – Withdrawal of Gamunex-C® (immune globulin [human])

Grifols Therapeutics announced a voluntary, consumer-level withdrawal of one lot of Gamunex-C (immune globulin [human]) injection due to a higher rate of allergic/hypersensitivity type reactions, a small number of which were considered medically significant. March 23, 2021

Ponvory™ (ponesimod) – New drug approval

Janssen announced the FDA approval of Ponvory (ponesimod), for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. March 19, 2021

Zegalogue® (dasiglucagon) – New drug approval

Zealand Pharma announced the FDA approval of Zegalogue (dasiglucagon), for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. March 23, 2021

Arcalyst® (rilonacept) – New orphan indication

Kiniksa Pharmaceuticals announced the FDA approval of Arcalyst (rilonacept), for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. March 18, 2021

Keytruda® (pembrolizumab) – Expanded indication

Merck announced the FDA approval of Keytruda (pembrolizumab), in combination with platinum- and fluoropyrimidine-based chemotherapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation. March 23, 2021