Pharmaceutical company Mallinckrodt Pharmaceuticals (NYSE:MNK) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for a Prior Approval Supplement for OFIRMEV
(acetaminophen) injection available in an intravenous (IV) bag presentation by the second quarter of 2017.
The addition of the high-growth OFIRMEV
injection boosts Mallinckrodt's increasing brands base and speciality pharmaceuticals portfolio of core controlled substance speciality generics, while ensuring a larger presence in the US hospital segment, the buyer said.
CADX is developing OFIRMEV
(acetaminophen) injection in the U.
His prior responsibilities include sales and marketing, commercial planning, product launch, healthcare economics, reimbursement, advocacy development, life cycle management, and business development for brands such as CERETEC, TAXUS, NATRECOR, RANEXA and OFIRMEV
The company's product Ofirmev
(acetaminophen injection) is a proprietary intravenous formulation of acetaminophen for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever.
acetaminophen injection is used for the management of mild to moderate pain.
Incline is developing its needle-free system, Ionsys, to deliver painkillers following surgery, while Cadence is trying to obtain regulatory approval for its experimental pain injection, Ofirmev
2m in Q1 of fiscal 2014, which was primarily driven by the inclusion and performance of HP Acthar Gel repository corticotropin injection and OFIRMEV
(acetaminophen) injection and higher net sales in its Specialty Generics segment.
5m in third-quarter net sales of its product OFIRMEV
(acetaminophen) injection, the first and only intravenous formulation of acetaminophen to gain approval in the US.
Following closing, Mallinckrodt adds OFIRMEV
(acetaminophen) injection, a high-growth, differentiated pain product, to its growing roster of brands and its robust Specialty Pharmaceuticals portfolio of core controlled substance specialty generics as well as an expanded presence in the US hospital channel.
M2 PHARMA-November 3, 2010-Cadence gains FDA nod for OFIRMEV
injection for pain and fever management(C)2010 M2 COMMUNICATIONS
This infusion of capital will support the company's potential launch of its investigational product candidate, OFIRMEV
, an intravenous formulation of acetaminophen that is currently marketed in Europe for the treatment of acute pain and fever, Oxford Finance said.