Sunday, July 10, 2011

Sunday Digest: 7/10/2011

So I've found lately that the FDA updates haven't had a lot of interesting material in them lately, but I do get interesting updates all week about all kinds of things, so I'm going to start including some of that in here. The end result (I hope) is that there will be more diversity, interesting and relevant material in the Sunday updates.

New Continuing Education
Understanding Female Infertility: Causes and Treatments
Written by Jennifer L. Gibson, PharmD and published by PharmQD. Cost is $6.50 to get credit, but the course is available for free if you're just interested in the material. Includes causes and treatment options.

Drug Recalls

No new ones.

New Drug Approvals

FDA Approves Arcapta Neohaler (indacaterol inhalation powder) for treatment of COPD
Indacaterol is a long-acting beta2 adrenergic agonists (LABA) and, as such, carries increased risk of asthma-related death (like formoterol). It is approved as a once-daily maintenance medication, not to be used as an emergency inhaler. Arcapta is manufactured and marketed by Novartis Consumer Healthcare.

Recent Generic Releases

Tentative Approvals for Olopatadine 0.1% Ophthalmic Solution
This will most likely be the AB-rated generic of Patanol. Though Pataday contains the same active ingredient, it is a higher concentration. Currently holding tentative approvals for the 0.1% concentration are:
  • Apotex
  • Sandoz
  • Wockhardt

Tentative Approvals for Duloxetine 20mg, 30mg, and 60mg Capsules
If granted full approval, this will be the AB-rated generic for Cymbalta. Currently holding tentative approvals are:
  • Impax
  • Zydus
  • Sun Pharmaceuticals
  • Wockhardt
  • Torrent
  • Sandoz
  • Aurobindo

Other Notices

Ista Pharmaceuticals' Bepreve Listed as Tier 3 on United Healthcare Formulary
Patanol and Pataday are being removed from the United Healthcare formulary (likely because of the upcoming generic switch). Ista pharmaceuticals is recommending doctors change their patients to Bepreve as an ophthalmic antihistamine. Personally, I think you should attempt a generic switch first, since tier 3 will likely be expensive.


Cheers, and happy Sunday.
C. Samuels

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