Alembic Pharma: Alembic Pharma gets USFDA nod for generic injection to treat cancer

Alembic Prescription drugs on Thursday mentioned it has obtained ultimate approval from the US well being regulator for its generic model of Paclitaxel injection used within the therapy of sure sorts of most cancers.

The approval granted by the US Meals & Drug Administration (USFDA) is for the abbreviated new drug software (ANDA) for Paclitaxel injection of strengths 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials.

“That is the primary product approval for oncology injection from our F-2 Facility (oncology injectable) which just lately accomplished the primary USFDA inspection,” Alembic mentioned in a regulatory submitting.

Paclitaxel injection is indicated as subsequent remedy for the therapy of superior carcinoma of the ovary.

Additionally, it’s indicated together with cisplatin as first-line remedy for the adjuvant therapy of node-positive breast most cancers administered sequentially to plain doxorubicin containing mixture chemotherapy, it added.

The corporate, citing IQVIA knowledge, mentioned Paclitaxel injection has an estimated market dimension of USD 26 million for 12 months ended June 30, 2022.