Last Updated on October 11, 2024 by The Health Master
Alembic Pharmaceuticals Limited (Alembic) announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor), has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for diclofenac sodium topical gel, 3%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze topical gel, 3%, of Fougera Pharmaceuticals Inc. (Fougera).
Diclofenac sodium topical gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy.
Diclofenac sodium topical gel, 3% has an estimated market size of US$ 10 million for twelve months ending March 2022 according to IQVIA. Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.
USFDA gives nod for generic birth control pills
USFDA gives nod for Belimumab to treat Paediatric Patients
USFDA gives nod for this generic high Blood Pressure drug
USFDA gives approval for this tablet to treat High BP
USFDA approves topical treatment addressing repigmentation
USFDA gives nod for this Blood Pressure injection
USFDA gives nod for generic birth control pills
New technology that deactivates COVID-19 virus in just 1 minute
Foreign MBBS holders: Registration only after 2 Years internship: NMC
USFDA gives nod for Belimumab to treat Paediatric Patients
CDSCO issues alert on Blood Purification Device hemoperfusion cartridge
CDSCO gives nod to make generic version of Pfizer’s Covid-19 pill
Norms for small Pharmaceutical firms may be eased
Govt invites applications to produce Vitamin B1
Govt plans to reduce the prices of critical drugs on August 15
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: