New Drug Approvals Archive - January 2018

Xgeva (denosumab)

New Indication Approved: January 4, 2018

• FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma
• Xgeva (denosumab) FDA Approval History

Fluarix (influenza virus vaccine, inactivated)

Patient Population Altered: January 11, 2018

• GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older
• Fluarix (influenza virus vaccine, inactivated) FDA Approval History

Lynparza (olaparib)

New Indication Approved: January 12, 2018

• FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
• Lynparza (olaparib) FDA Approval History

Gilotrif (afatinib)

New Indication Approved: January 12, 2018

• FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC
• Gilotrif (afatinib) FDA Approval History

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.

• Avion Pharmaceuticals Announces FDA Approval of Balcoltra (levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets) Oral Contraceptive
• Balcoltra (ethinyl estradiol/levonorgestrel and ferrous bisglycinate) FDA Approval History

Trulance (plecanatide)

New Indication Approved: January 25, 2018

• Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults
• Trulance (plecanatide) FDA Approval History

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.

• FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors
• Lutathera (lutetium Lu 177 dotatate) FDA Approval History

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.

• CutisPharma Announces FDA Approval of Firvanq (vancomycin) for Treatment of Clostridium Difficile Associated Diarrhea and Staphylococcus Aureus Colitis
• Firvanq (vancomycin hydrochloride) FDA Approval History