The US Food and Drug Administration (USFDA) has given the final approval to Alembic Pharma’s Paclitaxel injection USP, 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, a statement from Alembic pharma notified yesterday.

According to the statement, this is the first product approval for oncology injection from our F-2 Facility (oncology injectable) which recently completed the first USFDA inspection.

Further, the statement said that the approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Taxol injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL).

Click for more on USFDA

Paclitaxel injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.

As first-line therapy, it is indicated in combination with cisplatin for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy, added the statement.

Click for more on Alembic Pharma

In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors.

Paclitaxel injection has an estimated market size of $26 million for 12 months ending June 2022, according to IQVIA, the statement concluded.

Other drugs approval by USFDA

USFDA gives approval to this Blood Cancer therapy

USFDA grants final approval for Micafungin for injection

USFDA gives tentative approval for Valbenazine capsules

USFDA gives nod for Extended Phenytoin Sodium Capsules

USFDA gives final approval for Brivaracetam tablets

This State Pharmacy Council to appoint Pharmacy Inspectors

Medical Stores पर कार्रवाई: नशीली दवाई बेचने पर Licenses cancel, suspend

Two persons arrested in fake BP medicine racket

NPPA extends time limit for submission of data of Drugs & Medical Devices

USFDA gives approval to this Blood Cancer therapy

NPPA fixes retail price for diabetes drug combination Dapagliflozin & Sitagliptin

USFDA grants final approval for Micafungin for injection

DTAB ratifies Rule 46 of Medical Devices Rules, 2017

Dove shampoos recalled due to this reason

Latest Notifications regarding Pharmaceuticals
https://thehealthmaster.com/2022/10/29/usfda-gives-final-approval-for-paclitaxel-injection/