US FDA Approves Aurobindo Pharma’s Osteoarthritis Drug


Aurobindo Pharma’s, Aurolife Pharma LLC, has been granted final approval to manufacture and market Diclofenac Sodium Topical Solution by the US Food and Drug Administration (FDA).

Horizon Therapeutics Ireland DAC (Horizon)’s Pennsaid Topical Solution, a reference listed drug (RLD), and the approved product are bioequivalent and therapeutically comparable. Osteoarthritis can be treated with Diclofenac Sodium Topical Solution.

The product is anticipated to go on sale in Q1 of FY24. According to IQVIA, the market for the approved product is estimated to be $487 million for the twelve months ending December 2022. According to Aurobindo Pharma, this approval is the first abbreviated new drug application (ANDA) to get approved out of the Aurolife Unit-II, based in North Carolina, USA, which is used for producing topical products.

The pharmaceutical company’s share price increased by almost 6% on February 8, 2023, during the afternoon session after the company announced that its step-down subsidiary, Aurolife Pharma, had received approval from the US Food & Drug Administration (FDA) to manufacture and market Diclofenac Sodium Topical Solution USP. On the BSE, the stock was up Rs 24.75, or 5.91 percent, to Rs 443.40, making it one of the top midcap gainers.

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It has fluctuated between a low of Rs 415.35 and a high of Rs 443.60 on the same day. Volumes for the scrip were 157,834 shares, an increase of 178.44 percent from its five-day average of 56,684 shares.