Bunavail NDA

I have recently heard about the New Drug Application (NDA) for Bunavail medicine want to know about this in detail. Can you please provide me the FDA acceptance of the Bunavail medicine of NDA? Also tell me where is the authorized center where this drug was developed?

Hello sir, I want Bunavail New Drug Application approval letter. Is there any one can give me approval letter of Bunavail for New Drug Application?

[pooja]

The Bunavail was announced a approval letter for NDA. As per approval letter New Drug Application (NDA) was declared on dated August 6, 2013, received August 7, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for Bunavail (buprenorphine and naloxone) buccal film, 2.1 mg buprenorphine/ 0.3 mg naloxone, 4.2 mg buprenorphine/0.7 mg naloxone and 6.3 mg buprenorphine/1 mg naloxone.

The BioDelivery Sciences International, Inc. was submitted a 505(b)(2) new drug application (NDA) for buprenorphine/naloxone, formulated as a film that is intended for placement adjacent to the buccal mucosa.

There have been five NDAs containing buprenorphine approved:

Three sublingual tablet formulations intended for treatment of opioid dependence
Subutex (buprenorphine), NDA 20732
Suboxone (buprenorphine/naloxone), NDA 20733
Zubsolv (buprenorphine/naloxone), NDA 204242

Sublingual film formulation intended for treatment of opioid dependence
Suboxone (buprenorphine/naloxone) film, NDA 22410

Extended-release transdermal film formulation intended for the treatment pain
Butrans (buprenorphine), NDA 21306

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Here is PDF for Bunavail New Drug Application approval letter: