Alembic receives USFDA approval for Diclofenac Sodium Topical Solution

7 Dec 2022 , 01:33 AM

Alembic Pharmaceuticals has received final approval from the US Food amp; Drug Administration USFDA for its Abbreviated New Drug Application ANDA Diclofenac Sodium Topical Solution USP 2Percentage ww The ANDA was filed by Aleor Dermaceuticals Aleor which was amalgamated with Alembic

The approved ANDA is therapeutically equivalent to the reference listed drug product RLD Pennsaid Topical Solution 2Percentage ww of Horizon Therapeutics Ireland DAC Horizon

Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the kneesnbsp;

Diclofenac Sodium Topical Solution USP 2Percentage ww has an estimated market size of US$512 million for twelve months ending Sep 2022 according to IQVIA