FDA approves Lannett's ANDA for Hydrochlorothiazide Capsules, 12.5 mg

Lannett Company, Inc. (NYSE AMEX: LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Hydrochlorothiazide Capsules, 12.5 mg. Hydrochlorothiazide Capsules, 12.5 mg, is therapeutically equivalent to the reference listed drug, Microzide^® Capsules, 12.5 mg, of Watson Pharmaceuticals. Sales of Hydrochlorothiazide Capsules, 12.5 mg, at Average Wholesale Price (AWP) were approximately $204 million for the 12 months ending October 2011, according to Wolters Kluwer. Shipping is expected to commence shortly.

“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. We look forward to additional approvals over the next several months.”

"We have received approvals for and launched a record number products thus far in fiscal 2012, following a lack of approvals last year," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "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. We look forward to additional approvals over the next several months."

Hydrochlorothiazide is indicated in the management of hypertension.

Source Lannett Company, Inc.