Latebreakers: June 19, 2006

Pharmacy groups respond to EC commentary

Four national pharmacy groups have responded to a commentary on emergency contraception in the journal Obstetrics & Gynecology that argued that R.Ph.s should not be allowed to refuse to dispense medications based on their personal values because they lack the fundamental prerequisites to make clinically sound ethical decisions. APhA, ASHP, AMCP, and ACCP stated their support for a policy that ensures patients get their medications when an R.Ph. steps away from a script based on personal beliefs.

Tysabri given green light to return

Controversial review leads to approval for Sandoz growth hormone

Sandoz Pharmaceuticals, a division of Novartis, has received the long-awaited approval for Omnitrope (somatropin [rDNA origin]), a recombinant human growth hormone (GH). The FDA decision to approve Omnitrope was delayed after citizen petitions submitted to the agency raised questions regarding the regulatory, legal, and scientific issues associated with generic biologics. The FDA said, however, that Omnitrope is not a generic because it is not rated as therapeutically equivalent to any other human GH product already approved. Instead, the agency is referring to Omnitrope as a "follow-on protein product" to describe its similarity to GH products currently on the market. Manufacturers of follow-on protein products are allowed to rely on certain scientific knowledge about the safety and efficacy of previously approved products. Omnitrope is approved for long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous GH and for long-term replacement therapy in adults with either childhood or adult-onset GH deficiency.

Unique oral contraceptive OK'd

FDA approves vaccine to prevent shingles

Merck has been authorized by the FDA to begin marketing a new vaccine for the prevention of herpes zoster (shingles) in patients 60 years of age and older. Zostavax (Zoster Vaccine Live) was evaluated for efficacy in 38,546 men and women in the Shingles Prevention Study, and results showed the vaccine reduced the risk of developing shingles by 51%. Efficacy was highest among individuals aged 60 to 69 years and declined with advancing age. According to Merck, vaccination with Zostavax also reduced the incidence of long-term nerve pain from shingles in individuals 70 years of age and older who were vaccinated but then went on to develop the disease. Zostavax must be kept frozen during storage and will be available for ordering soon. The price is $145.35 per dose when purchased as a 10-pack of single-dose vials.