Lannett Company, Inc. has received approval from the US 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.
“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.
Lannett Company, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications.