BioCentury | Aug 10, 2018
Company News

FDA reviewers say data are lacking on TIRF drug use

...under the REMS, including four generics. Brand drugs include Subsys fentanyl sublingual spray and Fentora fentanyl effervescent buccal tablet...
...Subsys, and the Cephalon Inc. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) markets Fentora...
BioCentury | Aug 11, 2014
Strategy

Profusion of exclusions

...ü Transmucosal fentanyl analgesics Abstral fentanyl Galena Biopharma Inc. (NASDAQ: GALE)/Orexo AB (SSE:ORX; OTCQX:ORXOY) ü Fentora...
BioCentury | Oct 31, 2013
Targets & Mechanisms

KCC2 escape from neuropathic pain

...include Pfizer Inc. 's Lyrica pregabalin, a GABA receptor agonist; Teva Pharmaceutical Industries Ltd. 's Effentora...
BioCentury | Aug 5, 2013
Clinical News

Effentora fentanyl effervescent buccal tablet regulatory update

...biotech decided to withdraw an application seeking to expand the label of pain drug Effentora fentanyl effervescent buccal tablet...
...subsidiary markets the fast-dissolve transmucosal formulation of fentanyl as Effentora in the EU and as Fentora...
...A/S (CSE:LUN), Copenhagen, Denmark Taiho Pharmaceutical Co. Ltd. , Tokyo, Japan Product: Effentora fentanyl effervescent buccal tablet ( Fentora...
BioCentury | Jun 3, 2013
Strategy

Taiho goes global

...trifluorothymidine and a thymidine phosphorylase inhibitor Colorectal cancer Filed (Japan); Ph III (EU, U.S.) In-house Fentanyl effervescent buccal tablet...
BioCentury | Jan 2, 2012
Clinical News

Abstral fentanyl regulatory update

...transmucosal immediate-release fentanyl class include Abstral from Kyowa's subsidiary ProStrakan Group plc ; Actiq and Fentora...
...and Kyowa rights in Japan. H. Lundbeck has exclusive Canadian and Latin American rights to Fentora...
...EN 3267 , KW-2246 ); Actiq fentanyl ( TA-8317 ); Fentora ( Effentora - EU) fentanyl effervescent buccal tablet...
BioCentury | Dec 30, 2011
Top Story

FDA unveils REMS for fentanyl drugs

...program. Marketed drugs in the class include Abstral from ProStrakan Group plc ; Actiq and Fentora...
BioCentury | Dec 5, 2011
Strategy

Lundbeck psyched up

...armodafinil and Provigil modafinil; cancer drugs Treanda bendamustine, Trisenox arsenic trioxide, Myocet doxorubicin; and Fentora fentanyl effervescent buccal tablet...
...America Obtains exclusive rights to commercialize Treanda, Trisenox and Nuvigil in Canada and Provigil and Fentora...
BioCentury | Dec 5, 2011
Company News

Teva, Impax neurology news

...District of Delaware alleging an ANDA from Impax for a generic version of pain drug Fentora...
...7,862,832 B2 and 7,862,833 B2. The '604 and '590 patents cover methods of use for Fentora...
...21 & March 28). Cephalon markets the product as Fentora in the U.S. and as Effentora...
BioCentury | Jul 25, 2011
Clinical News

Fentora regulatory update

...FDA approved a REMS for Fentora fentanyl effervescent buccal tablet from Cephalon to manage breakthrough pain in opioid-tolerant patients...
...pain in opioid-tolerant patients with cancer. Under the REMS, pharmacy and healthcare professionals who prescribe Fentora...
...NASDAQ:CEPH), Frazer, Pa. H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Product: Fentora ( Effentora - EU) fentanyl effervescent buccal tablet...
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