Original New Drug Application Approvals by US FDA (16 - 31 August 2020)

New drug applications approved by US FDA as of 16 - 31 August 2020 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.

CYSTADROPS

• Active Ingredient(s): Cysteamine ophthalmic solution
• Strength: EQ 0.37% base
• Dosage Form(s) / Route(s): Solution/drops; ophthalmic
• Company: Recordati Rare
• Approval Date: 19 August 2020 
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
• Approved Label: 19 August 2020 (PDF)

PEMETREXED

• Active Ingredient(s): Pemetrexed
• Strength: 100 mg/4 mL (25 mg/mL); 500 mg/20 mL (25 mg/mL); 1 g/40 mL (25 mg/mL)
• Dosage Form(s) / Route(s): Solution; intravenous
• Company: Actavis LLC
• Approval Date: 21 August 2020
• Submission Classification: Type 2 - New Active Ingredient
• Indication(s): Not available
• Approved Label: Not available

METHOTREXATE

• Active Ingredient(s): Methotrexate
• Strength: 5 g/50 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Accord Healthcare, Inc.
• Approval Date: 24 August 2020
• Submission Classification: Not available
• Indication(s): Not available
• Approved Label: Not available

WINLEVI

• Active Ingredient(s): Clascoterone
• Strength: 1 g
• Dosage Form(s) / Route(s): Cream; topical
• Company: Cassiopea SPA
• Approval Date: 26 August 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Not available
• Approved Label: Not available

XARACOLL

• Active Ingredient(s): Bupivacaine HCl
• Strength: 300 mg
• Dosage Form(s) / Route(s): Implant; subcutaneous
• Company: Innocoll Pharmaceuticals
• Approval Date: 28 August 2020
• Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
• Indication(s): Indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair.
• Approved Label: 28 August 2020 (PDF)

SOGROYA

• Active Ingredient(s): Sompacitan-beco
• Strength: 10 mg/1.5 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Novo Nordisk, Inc.
• Approval Date: 28 August 2020
• Submission Classification: Not available
• Indication(s): Not available
• Approved Label: Not available