Lupin gets US nod for Sertraline
Domestic drug maker Lupin on Tuesday said USFDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for anti-depressant Sertraline Hydrochloride tablets in multiple dosage.
By PTI |
NEW DELHI: Domestic drug maker Lupin on Tuesday said USFDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for anti-depressant Sertraline Hydrochloride tablets in multiple dosage.
Lupin's Sertraline Hydrochloride tablets of 25mg, 50mg and 100mg would be the AB-rated generic equivalent of Pfizer's Zolsoft tablets and would help the company to corner sizeable market share in the $3.1 billion annual product sales of these kinds of tablets in the US.
Lupin intends to launch the generic version of Sertraline on final approval, which is expected upon expiration of marketing exclusivity for the product in February 2007, the company informed the Bombay Stock Exchange.
This is the 18th ANDA approval for the company till date.
Sertraline hydrochloride is an orally administered antidepressant of the selective serotonin reuptake inhibitor (SSRI) type.
Lupin's Sertraline Hydrochloride tablets of 25mg, 50mg and 100mg would be the AB-rated generic equivalent of Pfizer's Zolsoft tablets and would help the company to corner sizeable market share in the $3.1 billion annual product sales of these kinds of tablets in the US.
Lupin intends to launch the generic version of Sertraline on final approval, which is expected upon expiration of marketing exclusivity for the product in February 2007, the company informed the Bombay Stock Exchange.
This is the 18th ANDA approval for the company till date.
Sertraline hydrochloride is an orally administered antidepressant of the selective serotonin reuptake inhibitor (SSRI) type.
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