Cosela™ (trilaciclib) – New drug approval

The FDA announced the approval of G1 Therapeutics’ Cosela (trilaciclib), to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). February 12, 2021

Evkeeza™ (evinacumab) – New orphan drug approval

Regeneron announced the FDA approval of Evkeeza (evinacumab), as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH). February 11, 2021

Foscavir® (foscarnet) – First-time generic

Fresenius Kabi USA launched an AP-rated generic version of Clinigen’s Foscavir (foscarnet) injection. February 3, 2021

Lotemax® (loteprednol) – First-time generic

Akorn launched an AB-rated generic version of Bausch Health’s Lotemax (loteprednol) ophthalmic gel. February 11, 2021

Botox® (onabotulinumtoxinA) – New indication

Allergan announced the FDA approval of Botox (onabotulinumtoxinA), for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. February 10, 2021

Entresto® (sacubitril/valsartan) – Expanded indication

Novartis announced the FDA approval of Entresto (sacubitril/valsartan), to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adult patients with chronic heart failure (CHF). Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. February 16, 2021

Libtayo® (cemiplimab-rwlc) – New indication

Sanofi and Regeneron announced the FDA approval of Libtayo (cemiplimab-rwlc). February 9, 2021