Alembic Pharma JV Aleor gets tentative USFDA nod for therapeutic equivalent of Pennsaid Topical Solution

The approved ANDA(Diclofenac Sodium Topical Solution) is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP), said Alembic Pharma.

New Delhi: Alembic Pharmaceuticals Limited (Alembic) today announced that 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 to treat pain of osteoarthritis of the knee(s).

The approved ANDA(Diclofenac Sodium Topical Solution) is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP), said Alembic Pharma.

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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.

Headquartered in Vadodara, the company is involved in manufacturing pharmaceutical products, pharmaceutical substances and intermediates.

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