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PharmaSages_July FDA ApprovalsBOEHRINGER INGELHEIM: GILOTRIF (AFATINIB) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test .
JANSSEN BIOTECH: SIMPONI ARIA (GOLIMUMAB) is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate .
ASTELLAS: ASTAGRAF XL* (TACROLIMUS) is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.* New dosage form approved.
Following drugs got New formulation or new manufacturer approvals1) ZUBSOLV (BUPRENORPHINE; NALOXONE) from OREXO AB2) KHEDEZLA (DESVENLAFAXINE) from OSMOTICA PHARM3) ASTAGRAF XL (TACROLIMUS) from ASTELLAS4) LO MINASTRIN FE (NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;
FERROUS FUMARATE) from WARNER CHILCOTT LLC5) INJECTAFER (FERRIC CARBOXYMALTOSE) from LUITPOLD6) FETZIMA (LEVOMILNACIPRAN) from FOREST LABS INC
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