The Committee will review respiratory safety data comparing the therapy with its components.
The company's managing director and CEO Dr John Holaday said that the formal notification of the Advisory Committee date finalises the sequence of events which led to the previously announced PDUFA action date of 26 August.
MOXDUO, which is an immediate release Dual Opioid pain therapy, is a 3:2 fixed ratio combination of morphine and oxycodone.
Perrigo to acquire United States rights for Entocort from AstraZeneca
US FDA approves Boehringer Ingelheim's Pradaxa
Phase II clinical trial for potential treatment of androgenetic alopecia completed by Samumed
Life Sciences Partners collaborates on immuno-oncology with Bristol-Myers Squibb
Arsanis initiates first cohort in Phase one clinical trial of ASN100
Impax introduces generic Avodart (Dutasteride) Capsules, 0.5 mg
Mylan unveils generic FazaClo orally disintegrating tablets for treating schizophrenia