Alembic Pharma's JV Aleor gets USFDA tentative approval for Diclofenac Sodium Topical Solution

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.

Dec 02, 2019 06:12 IST India Infoline News Service

Alembic Pharmaceuticals
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.

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.

Stock view:
Alembic Pharmaceuticals Ltd is currently trading at Rs558, up by Rs5.75 or 1.04% from its previous closing of Rs552.25 on the BSE.

The scrip opened at Rs555 and has touched a high and low of Rs560.25 and Rs551.50 respectively.

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