.5) and Use in Specific Populations (8.6)].
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How SuppliedNo. 3062 — BELSOMRA tablets, 5 mg, are yellow, round, film-coated tablets, with "5" on one side and plain on the other side. They are supplied as follows: NDC 0006-0005-30 unit-of-use blisters of 30
No. 3063 — BELSOMRA tablets, 10 mg, are green, round, film-coated tablets, with "33" on one side and plain on the other side. They are supplied as follows: NDC 0006-0033-30 unit-of-use blisters of 30
No. 3981 — BELSOMRA tablets, 15 mg, are white, oval, film-coated tablets with the Merck logo on one side and "325" on the other side. They are supplied as follows: NDC 0006-0325-30 unit-of-use blisters of 30
No. 3982 — BELSOMRA tablets, 20 mg, are white, round, film-coated tablets with the Merck logo and "335" on one side and plain on the other side. They are supplied as follows: NDC 0006-0335-30 unit-of-use blisters of 30
16.2 Storage and HandlingStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.
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New Drugs Online Report for suvorexant
Information
Generic Name: suvorexant
Trade Name: Belsomra
Synonym: MK-4305
Entry Type: New molecular entity
Developmental Status
UK: Phase III Clinical Trials
EU: Phase III Clinical Trials
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Aug 14: Licensed in US at doses between 5 and 20mg [17].
14/08/2014 20:24:41
Apr 14: FDA accepts Merck´s resubmitted NDA [16].
19/06/2014 16:21:19
Jul 13: The company has received a Complete Response Letter from the FDA advising: the efficacy of suvorexant has been established at doses of 10mg to 40mg in elderly and non-elderly adult patients but the safety data do not support the approval of the 30mg and40 mg does; 10mg should be the starting dose for most patients, and must be available before suvorexant can be approved; 15mg and 20mg doses would be appropriate in patients in whom the 10mg dose is well-tolerated but not effective; for patients taking concomitant moderate CYP3A4 inhibitors, a 5mg dose would be necessary. Merck has determined that additional clinical studies of suvorexant 10mg will not be necessary. However, manufacturing studies will be required to advance the 10mg dosage form. Merck will discuss with the FDA whether additional studies will be required to support the 5mg dose [14]
02/07/2013 08:43:26
May 13:US FDA advisory committee has found clear evidence that suvorexant is quite effective in promoting sleep, but multiple safety issues call for lower doses. The FDA´s peripheral and central nervous system advisory committee reportedly agreed that the drug was generally safe and effective for treating sleep maintenance and latency. The panel voted 13-3, recommending lower starting doses of 15 mg for elderly and 20 mg for non-elderly. The panel delivered a split recommendation, seven for and eight against, on the safety of the higher doses of the product. [13]
24/05/2013 12:02:38
May 13: FDA is concerned that suvorexant may only be safe at doses lower than proposed: doses as |
