Lupin receives FDA nod for Chlorpromazine Hydrochloride Tablets

Lupin Inc., a wholly-owned subsidiary of the global pharmaceutical major Lupin Limited, announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP in various strengths.

The approval permits the New Jersey-based company to market a generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, originally by Upsher-Smith Laboratories, LLC.

The approved strengths for the generic Chlorpromazine Hydrochloride Tablets USP include 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg. The product will be manufactured at Lupin’s facility located in Somerset, U.S. Chlorpromazine Hydrochloride Tablets are used for treating a variety of mental and mood disorders and represent a significant market in the U.S.

As per the data from IQVIA, the estimated annual sales for Chlorpromazine Hydrochloride Tablets USP in the U.S. stood at around USD 45 million (MAT March 2023). This approval will allow Lupin to tap into this market, potentially expanding its presence in the U.S. pharmaceutical landscape.