- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- Diplomat becomes distributor of recently approved cancer drug
- Reports: ESI may start 'price war' over new hepatitis C drugs
- Senate passes Drug Quality and Security Act
- 21 health industry groups address FDA on proposed changes to generic drug label rules
PHILADELPHIA — Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.
The drug maker said its abbreviated new drug application for hydrochlorothiazide capsules in the 12.5-mg strength was approved. The drug is a generic version of Watson Pharmaceuticals' Microzide capsules.
“We have received approvals for and launched a record number products thus far in fiscal 2012, following a lack of approvals last year,” Lannett president and CEO Arthur Bedrosian said. “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.”