|
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.
|