FDA approves generic contraceptive pill
NEW YORK The approval of Watson Pharmaceutical’s ANDA for levonorgestrel tablets, otherwise known as the emergency contraceptive Plan B, marks the first time a generic company gained prescription-only approval for one month, even as it awaits nonprescription approval for the same drug a few months down the line.
Of course, it’s fitting, as Plan B is the only medicine available as both a prescription and nonprescription remedy at the same strength and for the same indication, the only distinguishing factor being the age of the patient.
Watson, citing IMS Health data, noted that Plan B generated $123 million for the 12 months ended March 2009, 10% of which consisted of Plan B prescriptions for use in women younger than 18. Watson will be launching the product under the brand name Next Choice.
The Watson product may be dispensed without a prescription in nine states, however, as those states still allow a pharmacist to dispense the emergency contraceptive with a standing prescription from a local doctor.
The Food and Drug Administration stated that an OTC approval of generic Plan B won’t be forthcoming until after Aug. 12, which is when the OTC-switch exclusivity period expires. What will be interesting is whether or not this second approval will renew media interest in this hot-button medicine — Secretary of State Hillary Clinton and Sen. Patty Murray, D-Wash., refused to confirm FDA commissioner Andrew von Eschenbach in 2006 until the FDA made a decision around switching Plan B.
And while there may not be any political fallout with a Democratic House and Hill, the emergency contraceptive has long raised an issue around patient access to convenient and effective medicines, versus the right of a pharmacist to refuse to dispense that medicine out of conscientious objection.
Perrigo promotes McCormick to consumer healthcare pricing and planning manager
ALLEGAN, Mich. Perrigo earlier this week promoted Shawn McCormick to consumer healthcare pricing and planning manager, where he will be responsible for managing pricing and business planning functions within CHC marketing.
McCormick, a four-year Perrigo veteran, most recently served as the CHC sales and marketing controller. Before joining Perrigo, he worked for Steelcase in finance and with BDO Seidman in auditing.
A Certified Public Accountant, McCormick earned his Bachelor’s of Business Administration in Accounting from Grand Valley State University in 2001.
Bausch & Lomb Vision Care adjusts focus on lens care
ROCHESTER, N.Y. Bausch & Lomb Vision Care on Friday announced a renewed focus on its ReNu brand of lens care solutions through a U.S. consumer rebranding effort that targets both eye care practitioners and consumers with messaging around ReNu Fresh Lens Comfort (formerly ReNu MultiPlus) and ReNu Sensitive Eyes (formerly ReNu Multipurpose Solution). New packaging around Sensitive Eyes begins shipping this month.
Additionally, the company recently established a dedicated U.S. lens care solution and eye care product sales force that primarily is responsible for engaging with eye care practitioners and keeping them updated on the benefits of B&L products for their patients and their practice. The sales team presently is focusing on eye care professionals across the East Coast, and will be moving its emphasis to the West Coast by next year.
“We felt that it was time to rejuvenate our original ReNu brand of lens care solutions … that clearly articulates the specific benefits of each formula,” stated Steven Robins, president, North America, Vision Care. “With ReNu Fresh Lens Comfort and ReNu Sensitive Eyes, we can more directly help meet existing consumer needs, such as the desire for a fresh lens feeling daily or for a solution that is gentle enough for sensitive eyes.”
B&L also has launched a fully integrated consumer marketing campaign, which includes www.renufresh.com, a free-standing advertising insert distributed in newspapers nationally, in-store shelf talkers and banners and an online advertising and search keyword campaign.
The Web site, which features lens care information and tips for consumers, includes a B&L Wear & Care video and a coupon for the Fresh Lens Comfort solution. Consumers also are able to vote for their favorite fresh image of the day.