The US Food and Drug Administration (FDA) on Tuesday issued new draft guidance providing labeling recommendations for hormonal contraceptives in line with requirements from the agency's 2006 physician labeling rule (PLR) and 2014 pregnancy and lactation labeling rule (PLLR). FDA had previously issued draft guidance on combined oral contraceptive (COC) labeling in 2004, but withdrew the guidance in 2015. However, FDA says it took comments submitted to the 2004 draft gui...

The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent. The reversal of the lower court decision could mean a loss of patent protection and the launch of new Safyral and Beyaz generics before the patent expires in April 2020. The story and patent claim on the contraceptives...