FDA: Nitrosamine Impurity Identified in Commonly Used Acid Suppressant
NDMA was one of several nitrosamine impurities implicated in the massive recall of angiotensin II receptor blockers (ARBs) since last year.
NDMA was one of several nitrosamine impurities implicated in the massive recall of angiotensin II receptor blockers (ARBs) since last year.
In the study, albuterol and epinephrine were tied to the most cases after excluding metformin and NRTIs.
Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) have been made available by Amgen and Allergan.
The FDA has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.
Kanjinti, a HER2/neu receptor antagonist, is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative.
The FDA has approved Keytruda (pembrolizumab; Merck) for first line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma as monotherapy for patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil (FU) regardless of PD-L1 expression.
The FDA has approved Piqray (alpelisib; Novartis) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
The FDA has approved the NovoTTF-100L System (Novocure) in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma.
The FDA has approved Venclexta in combination with Gazyva for the treatment of patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.