From the ArcaMax Publishing, Science & Technology Newsletter:
http://www.arcamax.com/news/technology/s-570581-551161
WASHINGTON (UPI) -- The U.S. Food and Drug Administration has approved
the first generic version of emergency contraceptive Plan B
(levonorgestrel) tablets.
The FDA said the generic product will be available by prescription
only for women ages 17 and under.
Plan B was first approved in 1999 for prescription use for women of
all ages. In 2006, Plan B was approved for non-prescription use for
women ages 18 and older while still available as a prescription-only
product for women ages 17 and under.
The FDA's Wednesday approval allows marketing of a prescription-only
generic product for women ages 17 and under. The federal agency said
no generic levonorgestrel product for emergency contraception can be
approved for non-prescription use in women ages 18 and older until
Aug. 24 when the marketing exclusivity for non-prescription use
expires.
Generic levonorgestrel tablets 0.75 milligram are made by Watson
Laboratories Inc. of Corona, Calif.
Plan B is manufactured by Duramed Pharmaceuticals Inc. of Cincinnati.