HQ Team
March 20, 2023: India’s Glenmark Pharmaceuticals has got the final approval by the USFDA for its generic prochlorperazine maleate tablets, the generic version of compazine of GlaxoSmithKline.
Glenmark’s prochlorperazine maleate tablets of 5mg and 10mg will be distributed in the US by Glenmark Pharmaceuticals Inc., USA., according to a BSE filing.
Prochlorperazine treats nausea, migraines, schizophrenia, psychosis and anxiety. It is a less preferred medication for anxiety. It may be taken by mouth, rectally, injected into a vein, or injection into a muscle.
The FDA approved the abbreviated new drug application (ANDA) of Glenmark. ANDA contains data submitted to the FDA for a generic drug product’s review and potential approval.
Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references.
$26.9 million market
According to the research firm IQVIA, sales data for the 12 months ending January 2023 for compazine tablets, 5mg and 10mg market stood at about $26.9 million.
Glenmark’s current portfolio consists of 182 products authorized for distribution in the US and 46 ANDAs pending approval with the US FDA.
In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio, according to the statement.
