Alembic Pharmaceuticals joint venture received USFDA approval for Diclofenac Sodium Topical Solution

  • Posted on: 2 December 2019
  • By: admin

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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.

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