This double dose plan-B is already available in India. You will already find it listed in our Price List (www.genericmedicine.com).

Supplied Product Name- iPill (1.5mg tablet) from Cipla Ltd, India.

As FDA approves single-dose Plan B, Teva touts advantages

17 July 2009 by Nancy Faigen

Teva Pharmaceutical Industries has recently received approval from the US FDA to market its emergency contraceptive Plan B (levonorgestrel) in a new dosage formulation that requires a single 1.5mg tablet, instead of two 0.75mg tablets which need to be taken 12 hours apart. Teva touts as an advantage the fact that the new formulation, Plan B One-Step, can be taken “right away” after unprotected sex has occurred. It is known that Emergency contraception is more effective the sooner it is taken. Plan B One-Step is expected to be in retail pharmacies in August, Teva said. The new formulation will replace the two-pill formulation in Teva’s product line just as the original Plan B product loses its US exclusivity (as an OTC product) on August 24th. Pricing of the new single-tablet formulation has not been announced, but industry observers believe it might be similar to the original Plan B product, which costs $49.99 on the on-line retailer drugstore.com. In addition to approving the single-dose emergency contraceptive, the FDA has also expanded OTC access to both Plan B One-Step and the original two-dose Plan B, and will make them available to consumers age 17 or older. The FDA said in April it would provide no objections to a judge’s order to allow the OTC sales to 17-year olds (scripnews.com, April 24th, 2009). Both products will be available for women younger than 17 years of age only by prescription. Many healthcare workers view the original Plan B product as posing limitations, because it requires careful timing that may not be convenient for a patient. Jennifer Rogers who is the acting executive director for Reproductive Health Technologies Project, told Newsweek, “Sometimes, with two doses, women would delay taking their first pill. If you buy it at 2pm, but don’t want to wake up at 2am, you may wait another six hours to begin the course of treatment.” She added, “For us, one pill makes the most sense.”The US data sheet for Plan B One-Step outlines the clinical efficacy of the new formulation. It states: “In the Plan B Step-One group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20 pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. Among women receiving Plan B One-Step, 84% of expected pregnancies were prevented and among those women taking Plan B, 79% of expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B One-Step.” Last month, the FDA approved the first ANDA for the two-dose formulation, from Watson Laboratories. Watson plans to launch its generic product shortly, under the trade name Next Choice. For now, its two-dose 0.75mg formulation will only be available by prescription. Visit genericmedicine.com to buy this product

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