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FDA approves Lannett ANDA for Hydrochlorothiazide Capsules

PBR Staff Writer Published 31 January 2012

Lannett Company has received FDA abbreviated new drug application (ANDA) approval for Hydrochlorothiazide Capsules, 12.5mg.

Hydrochlorothiazide Capsules, 12.5mg, indicated for the management of hypertension, is therapeutically equivalent to the reference listed drug, Microzide Capsules, 12.5mg, of Watson Pharmaceuticals.

The company is expected to commence shipment of the product shortly.

Lannett president and CEO Arthur Bedrosian said that they have received approvals for and launched record number products thus far in fiscal 2012.

"Hydrochlorothiazide is an important addition to our offering and represents the eighth product approval (seven ANDAs and one NDA) we have received over the last seven months," Bedrosian added.

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