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Alembic's JV Aleor Dermaceuticals receives USFDA tentative approval for Diclofenac Sodium Topical Solution

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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.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, December 02 2019. 11:54 IST
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