Alembic Pharma JV Gets USFDA Nod For Diclofenac Sodium

Alembic Pharmaceuticals announced that the company’s joint venture, Aleor Dermaceuticals, has received US Food and Drug Administration (USFDA) Tentative Approval for 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.

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.-Business Standard