USFDA gives final approval to this breast cancer injection

According to IQVIA, Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$71 million for twelve months ending September 2022.

155
USFDA Approval
USFDA Approval

Last Updated on October 6, 2024 by The Health Master

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe.

According to a press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.

According to IQVIA, Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US$71 million for twelve months ending September 2022.

Alembic Pharmaceuticals has received a cumulative total of 179 ANDA approvals (156 final approvals and 23 tentative approvals) from the USFDA.

USFDA gives approval for Fulvestrant injection

USFDA gives approval for this Genetic Disorder drug

USFDA gives approval for Lymphoma Therapy

USFDA gives approval for Pregabalin capsules

USFDA gives approval for Brivaracetam Tablets

USFDA approves Gene Therapy for Bladder Cance

NPPA releases draft calculation sheet for ceiling price revision of 35 formulations

CDSCO and States starts joint inspections of Drug Manufacturing Units

DCGI calls for registering (MDTLs) Medical Devices Testing Laboratories

USFDA gives approval for Fulvestrant injection

USFDA gives approval for this Genetic Disorder drug

USFDA changes Plan B label of Contraceptive Pills

Confession in criminal proceedings: Ground for conviction ?

Registration for sale of Medical Devices: Procedure and conditions

Bulk transfer of Blood and Blood Components: Procedure and Conditions

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news