Drug Shortage – bupivacaine/epinephrine injection
The drug shortage of bupivacaine/epinephrine injection products is ongoing. These products have been unavailable for at least 90 days. March 8, 2021
Drug Shortage – Ethyol® (amifostine)
The drug shortage of Clinigen’s Ethyol (amifostine) injection is ongoing. Ethyol has been unavailable for at least 90 days. March 8, 2021
Azstarys™ (serdexmethylphenidate/dexmethylphenidate) – New drug approval
KemPharm announced the FDA approval of Azstarys (serdexmethylphenidate/dexmethylphenidate), for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years of age and older. March 2, 2021
Azopt® (brinzolamide) – First-time generic
Teva launched an AB-rated generic version of Novartis’ Azopt (brinzolamide) 1% ophthalmic suspension. March 8, 2021
Hysingla™ ER (hydrocodone bitartrate) – First-time generic
Alvogen launched an AB-rated generic version of Purdue Pharma’s Hysingla ER (hydrocodone) extended-release tablets. March 4, 2021
Actemra® (tocilizumab) – New indication
Genentech announced the FDA approval of Actemra (tocilizumab), for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). March 4, 2021
Keytruda® (pembrolizumab) – Indication withdrawal
Merck announced the voluntary withdrawal of the Keytruda (pembrolizumab) indication for treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. March 1, 2021
Lorbrena® (lorlatinib) – Expanded indication
Pfizer announced the FDA approval of Lorbrena (lorlatinib), for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. March 3, 2021
Tecentriq® (atezolizumab) – Indication withdrawal
Roche announced the voluntary withdrawal of the Tecentriq (atezolizumab) indication for patients with prior-platinum treated metastatic urothelial carcinoma (mUC). March 8, 2021
Yescarta® (axicabtagene ciloleucel) – New indication
Kite, a Gilead Company, announced the FDA approval of Yescarta (axicabtagene ciloleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. March 5, 2021