Original New Drug Application Approvals by US FDA (1 -15 June 2018)

New drug applications approved by US FDA as of 1-15 June 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

    FULPHILA

• Active Ingredient(s): Pegfilgrastim-JMDB
• Strength: 6 mg/0.6 ml
• Dosage Form: Injectable;injection
• Company: Mylan GMBH
• Approval Date: June 04, 2018
• Submission Classification: Not applicable
• Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Approved Label: 06/04/2018(PDF)

• Active Ingredient(s): Moxidectin
• Strength: 2 mg
• Dosage Form: Tablet;oral
• Company: Medicines Development for Global Health
• Approval Date:  June 13, 2018
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
• Approved Label: 06/13/2018(PDF)

• Active Ingredient(s): Doxycycline Hyclate
• Strength: 100 mg
• Dosage Form: Tablet;oral
• Company: Chartwell Pharma
• Approval Date: June 15, 2018
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for  the treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above.
• Approved Label: 06/15/2018(PDF)