Upsher-Smith Laboratories, LLC
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Latest From Upsher-Smith Laboratories, LLC
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
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.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
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.
Upsher-Smith Shuffles Portfolio With A Pair Of Deals
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.
Sawai Focuses On New Products, Supply To 'Retain Trust' of Japan Generic Industry
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.
- Generic Drugs
- OTC, Consumer
- Specialty Pharmaceuticals
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