scorecardresearch

Aleor Dermaceuticals Limited receives USFDA final approval for Diclofenac Sodium Topical Gel

Meanwhile, the company also stated that Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

Aleor Dermaceuticals, Alembic Pharmaceuticals, Diclofenac Sodium Topical Gel, health news, pharma news,
Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. (File)

Alembic Pharmaceuticals Limited (Alembic) on Friday 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%.

According to the company’s press statement, 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 Mar., 2022 according to IQVIA, the pharma company claims.

Meanwhile, the company also stated that Alembic has received a cumulative total of 169 ANDA approvals (145 final approvals and 24 tentative approvals) from USFDA.

Get live Share Market updates and latest India News and business news on Financial Express. Download Financial Express App for latest business news.