Panel favors elimination of 19-day lockout after patients who can become pregnant miss the first prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.

Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.

Sawai’s Upsher-Smith business in the US has announced a pair of deals that will see the firm expand an existing partnership with Appco for a “near-term generic product opportunity” as well as divesting two “dormant” ANDAs in favor of a focus on more immediate assets.

Looking back at recent company decisions to shift product strategy, restructure its US Upsher-Smith business and acquire manufacturing sites from a former domestic competitor, Sawai's president shares the breadth of the Japanese firm’s vision.