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New Drug Approvals Archive - January 2018

See also: New Indications and Dosage Forms for January 2018

January 2018

Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) Tablets

Date of Approval: January 9, 2018
Company: Avion Pharmaceuticals, LLC
Treatment for: Prevention of Pregnancy

Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) is a progestin/estrogen combination oral contraceptive (COC) indicated for use by females of reproductive potential to prevent pregnancy.

Lutathera (lutetium Lu 177 dotatate) Injection

Date of Approval: January 26, 2018
Company: Advanced Accelerator Applications S.A.
Treatment for: Gastroenteropancreatic Neuroendocrine Tumors

Lutathera (lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Firvanq (vancomycin hydrochloride) for Oral Solution

Date of Approval: January 26, 2018
Company: CutisPharma
Treatment for: Clostridium Difficile Associated Diarrhea; Enterocolitis

Firvanq (vancomycin hydrochloride) is an oral solution formulation of an approved tricyclic glycopeptide antibiotic for the treatment of Clostridium difficile associated diarrhea and Staphylococcus aureus enterocolitis.

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