The Canadian company said that Silenor
(doxepin hydrochloride) is available in 3mg or 6mg oral tablets indicated for the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening and/or early morning awakenings.
Expenses related to Silenor
development work also decreased because a higher level of activity relating to the preparation of the NDA and the conduct of non-clinical studies was ongoing during the first quarter of 2008 compared to the first quarter of 2009.
Specialist pharmaceutical company Paladin Labs Inc (TSX:PLB.TO) said on Monday that it has received approval from Health Canada for Silenor
(doxepin hydrochloride) for the treatment and symptomatic relief of insomnia characterised by frequent nocturnal awakening and/or early morning awakenings.
During the meeting, which Somaxon attended together with its partner in the Selenor product, Procter & Gamble (NYSE:PG), the FDA gave its clinical and regulatory guidance that Somaxon will take into account in developing an OTC version of Silenor
27 August 2010 - US Somaxon Pharmaceuticals Inc (NASDAQ: SOMX) said on Wednesday it has signed a co-promotion agreement with Procter & Gamble (NYSE: PG) for Silenor
(doxepin), a newly-approved treatment for insomnia characterised by difficulty with sleep maintenance.
Paladin Labs Inc (TSX:PLB.TO) and Somaxon Pharmaceuticals Inc (Nasdaq:SOMX) revealed jointly on Wednesday the acceptance of a New Drug Submission (NDS) for review by Health Canada for Silenor
(doxepin) for the treatment and symptomatic relief of insomnia.
Somaxon held a meeting with senior leadership at the US Food and Drug Administration (FDA) on 20 January 2010 to discuss the issues raised by the FDA in the Complete Response Letter (CRL) Somaxon received in December 2009 relating to the Silenor
Pharmaceutical company Somaxon Pharmaceuticals Inc (Nasdaq:SOMX) on Wednesday revealed that it has entered into an exclusive collaboration agreement with Paladin Labs Inc (TSX:PLB.to) to commercialise Somaxon's treatment for insomnia, Silenor
, in Canada, South America and Africa.
Somaxon defers revenue recognition of the amounts of Silenor
shipments to wholesale distributors that are not yet estimated to be dispensed through patient prescriptions.
Somaxon added the patent application generally relates to dosing Silenor
at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation.
Speciality pharmaceutical company Somaxon Pharmaceuticals Inc (NASDAQ:SOMX) revealed on Tuesday that the company plans to take on 35 more sales representatives that will exclusively promote Silenor
M2 EQUITYBITES-November 3, 2010-Somaxon Pharmaceuticals Inc secures USD245,000 grant for Silenor
under QTDP programme(C)2010 M2 COMMUNICATIONS http://www.m2.com