[UPDATE 9/6/18] Lynparza capsules were withdrawn from the market to avoid confusion and potential dosing errors with the tablets, and to reduce the pill burden, according to a statement from a company representative.
The Food and Drug Administration (FDA) has posted a discontinuation notice for Lynparza (olaparib; AstraZeneca) 50mg capsules in 112-count bottles. The Company has not disclosed a reason for the medication discontinuation, however in 2017, the FDA reported that olaparib capsules were being phased out of the US market. Lynparza capsules are indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with ≥3 prior lines of chemotherapy.
Lynparza will still be available as 100mg and 150mg strength tablets in 60- and 120-count bottles. The tablet formulation is indicated for the maintenance treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in adults who are in complete or partial response to platinum-based chemotherapy; treatment of deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer in adults who have been treated with ≥3 prior lines of chemotherapy; and for the treatment of deleterious or suspected deleterious germline BRCA-mutated, HER2-negative (as detected by an FDA-approved test) metastatic breast cancer in patients who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting (patients with HR-positive breast cancer should have been treated with prior endocrine therapy or be considered inappropriate for endocrine therapy).
Lynparza capsules and tablets are not interchangeable.
For more information call (800) 236-9933 or visit FDA.gov.