Alembic Pharmaceuticals joint venture received USFDA approval for Diclofenac Sodium Topical Solution
Alembic Pharmaceuticals’s joint venture, Aleor Dermaceuticals Limited, has received US Food and Drug Administration (USFDA) Tentative Approval for Diclofenac Sodium Topical Solution USP, 2% w/w.
Alembic Pharmaceuticals Limited (Alembic) and its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2% w/w.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP). Diclofenac Sodium Topical Solution USP, 2% w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Diclofenac Sodium Topical Solution USP, 2% w/w, has an estimated market size of US$ 974 million for twelve months ending December 2018 according to IQVIA.
Alembic has a cumulative total of 109 ANDA approvals (96 final approvals and 13 tentative approvals) from USFDA.