On February 1st Orexigen(R) Therapeutics, Inc. and Takeda Pharmaceutical Company Limited (Takeda) announced that the FDA issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss (http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1522207&highlight=). In the letter, FDA [...]
Archive for February, 2011
Contrave® Rejection: The Long and the (Too) Short of it
Published February 21st, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsMitosol – an Orphan & 505(b)(2) without clinical studies
Published February 7th, 2011 in 505(b)(2) Process and News Commentary. 0 CommentsMobius Therapeutics announced that it has received orphan drug status for Mitosol to prevent the recurrence of pterygium after surgical excision. The active ingredient, mitomycin has been used without FDA approval for eye surgeries since the mid 1960′s. Due to its long history of use, the FDA did not require that Mobius conduct clinical trials. [...]
Injectables: 505j or 505(b)(2)?
Published February 1st, 2011 in 505(b)(2) Issues, ANDA's and Formulation Issues. 0 CommentsGeneric injectable drug products are treated differently than other routes of administration when it comes to permitted differences from the RLD. For most dosage forms, the sponsor is allowed to change excipients as long as the test product is bioequivalent to the RLD. No so for injectables, the excipients must be the same. If the [...]
Approvals of ANDAs slows
Published February 21st, 2011 in ANDA's, Events and News Commentary. 0 CommentsI attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are slowing and there is a growing awareness that the root cause is not just the Office of Generic Drugs (OGD). As [...]