1. PharmaSages_July FDA Approvals
BOEHRINGER 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 approvals
1)ZUBSOLV (BUPRENORPHINE; NALOXONE) from OREXO AB
2)KHEDEZLA (DESVENLAFAXINE) from OSMOTICA PHARM
3)ASTAGRAF XL (TACROLIMUS) from ASTELLAS
4)LO MINASTRIN FE (NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;
FERROUS FUMARATE) from WARNER CHILCOTT LLC
5)INJECTAFER (FERRIC CARBOXYMALTOSE) from LUITPOLD
6)FETZIMA (LEVOMILNACIPRAN) from FOREST LABS INC

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Ajay Shrivastava, CEO
PharmaSages
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E-mail:asbiopro@pharmasages.com
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