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Approvals for Celgene, Allergan; designations for J&J, Arvinas

Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 31.


* Celgene Corp.'s Revlimid in combination with Roche Holding AG's Rituxan for patients with follicular lymphoma and marginal zone lymphoma whose disease had returned or did not respond to treatment.

* Allergan PLC and Gedeon Richter PLC's Vraylar for depressive episodes associated with bipolar 1 disorder in adults. The drug was previously approved for treating manic or mixed episodes associated with bipolar 1 disorder in adults.

* Hologic Inc.'s Aptima BV and Aptima CV/TV tests to detect vaginitis caused by bacterial vaginosis, vulvovaginal candidiasis and trichomonas vaginalis infections.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Johnson & Johnson's Darzalex in combination with chemotherapy bortezomib, thalidomide and dexamethasone to treat newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant. Darzalex was previously approved to treat multiple myeloma patients who are ineligible for stem cell transplant.

* Amarin Corporation PLC's Vascepa for heart patients who are already on statin therapy to control LDL-C cholesterol and have high levels of triglycerides. The drug is already approved to be used in supplement with the diet for patients with severe hypertriglyceridemia.

Fast track

* Arvinas Inc.'s ARV-110 for men with castration-resistant prostate cancer that has spread to other parts of the body and whose disease progressed after receiving two or more systemic therapies.

* Zymeworks Inc.'s ZW25 as the first-line treatment for patients with HER2-overexpressing gastroesophageal adenocarcinoma to be used in combination with standard of care chemotherapy.

Other designations

* Orphan drug, for Applied Therapeutics Inc.'s AT-007 for galactosemia.

* Regenerative medicine advanced therapy, for Fibrocell Science Inc.'s FCX-007 for recessive dystrophic epidermolysis bullosa.