Replies to post #53279 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

Again.....what are the 3 FDA pathways that Elite can use to get an abuse resistant drug approved??? Once you spell that out you will have your answer.

[lasers]

Embeda is 505b2 NDA


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf


"Please refer to your new drug application
(NDA) dated June 30, 2008, received June 30, 2008,
submitted pursuant to section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act for
EMBEDA (morphine sulfate and naltrexone hyd
rochloride) Extended-Release Capsules, 20
mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60
mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg. "

[lasers]

Embeda is 505b2 NDA

Please refer to your new drug application
(NDA) dated June 30, 2008, received June 30, 2008,
submitted pursuant to section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act for
EMBEDA (morphine sulfate and naltrexone hyd
rochloride) Extended-Release Capsules, 20
mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60
mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg.


If you have any questions, call Lisa Basham,
Regulatory Project Mana
ger, at [phone].
Sincerely,
{See appended electr
onic signature page}
Bob A. Rappaport, MD
Director
Division of Anesthesia, Analgesia and
Rheumatology Products
Office of Drug Evaluation II
Center for Drug Evaluation and Research

BOB A RAPPAPORT
08/13/2009

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf