Skytrofa® (lonapegsomatropin-tcgd) – New orphan drug approval
Ascendis Pharma announced the FDA approval of Skytrofa (lonapegsomatropin-tcgd), for the treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH). August 25, 2021
Briviact® (brivaracetam) – Expanded indication
UCB announced the FDA approval of Briviact (brivaracetam), for the treatment of partial-onset seizures in patients 1 month of age and older. August 30, 2021
Tecentriq® (atezolizumab) – Indication withdrawal
Roche announced the voluntary withdrawal of the Tecentriq (atezolizumab) indication for use in combination with paclitaxel protein-bound, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. August 27, 2021
Tibsovo® (ivosidenib) – New indication
Servier Pharmaceuticals announced the FDA approval of Tibsovo (ivosidenib), for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
Invega Hafyera Approved
Janssen’s Invega Hafyera™ (paliperidone palmitate) extended-release injectable suspension received approval from the U.S. Food and Drug Administration (FDA) on. It is a new longer-acting version of the atypical antipsychotic that is administered by intramuscular (IM) injections twice each year by a healthcare provider to treat adults who have schizophrenia. August 30, 2021
Trudhesa – FDA Approves
A new brand of dihydroergotamine (DHE) mesylate was FDA approved on. Impel NeuroPharma’s Trudhesa™ nasal spray is indicated to treat adults who have acute migraine headaches whether or not they are accompanied by auras. Sept 2, 2021
Brukinsa – Second Indication Awarded
Brukinsa® (zanubrutinib – BeiGene) capsules was FDA approved on Aug. 31, 2021, to treat adults who have Waldenström’s macroglobulinemia (WM). A rare type of non-Hodgkin lymphoma, WM is most common among older adults.
Keytruda Indication Revised
Accelerated Approval is given by the FDA for drugs that show promise for treating serious or life-threatening diseases in clinical studies, even though the studies have not been completed.
Teligent Pharma Recall
Teligent Pharma recalled one lot of lidocaine topical solution, 4% in 50mL bottles. Testing of samples from the recalled lot found it to be much stronger than indicated on the label. Aug. 27, 2021