The agency is expected to complete the review of the application on February 3, 2014.
VersaFilm contains Rizatriptan, the active drug in US Merck & Co's (NYSE:MRK) Maxalt-MLT orally disintegrating tablets.
IntelGenx has developed the product in collaboration with Israeli RedHill Biopharma Ltd (TLV:RDHL).
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