- FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose
- FDA advisory panel to consider OTC status of NSAIDs
- FDA advisory committees vote against changing naproxen label to highlight a lower CVD profile
- Mallinckrodt receives FDA approval for Xartemis XR
- ROUNDTABLE: Pharmacy’s future in sync with technology
PHILADELPHIA—Lannett has started shipping a painkiller product approved by the Food and Drug Administration in June, the company said.
Lannett announced the shipment of morphine sulfate oral solution. Lannett sought FDA approval using a 505(b)(2) new drug application. Sales of morphine sulfate oral solution at average wholesale price were $31.7 million during the 12-month period ending in June, according to Wolters Kluwer.
"This is our first drug approval using a 505(b)(2) application," Lannett president and CEO Arthur Bedrosian said. "We have received orders from drug wholesalers, nursing home providers and distributors."