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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.

New Drug Approvals Archive

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