Original New Drug Application Approvals by US FDA (16 - 31 October 2018)

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

TALZENNA

• Active Ingredient(s): Talazoparib
• Strength: 0.25 mg, 1 mg
• Dosage Form: Capsule; oral
• Company: Pfizer Inc.
• Approval Date: October 16, 2018
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for  the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
• Approved Label: 10/16/2018(PDF)

• Active Ingredient(s): Levoleucovorin
• Strength: 175 mg, 300 mg
• Dosage Form: Injectable; injection
• Company: Spectrum Pharms
• Approval Date: October 19, 2018
• Submission Classification: Type 2 - New Active Ingredient
• Indication(s): Indicated for 
• Rescue after high-dose methotrexate therapy in patients with osteosarcoma
• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination. 
• Treatment of patients with metastatic colorectal cancer in combination with fluorouracil
• Approved Label: 10/19/2018(PDF)

• Active Ingredient(s): Baloxavir Marboxil
• Strength: 20 mg, 40 mg
• Dosage Form: Tablet;oral
• Company: Shionogi Inc
• Approval Date: October 24, 2018
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. 
• Approved Label: 10/24/2018(PDF)

• Active Ingredient(s): Estradiol; Progesterone
• Strength:  1 mg, 100 mg
• Dosage Form: Capsule; oral
• Company: Therapeuticsmd Inc
• Approval Date: October 28, 2018
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms due to menopause.  

• Active Ingredient(s): Adalimumab-adaz
• Strength: 40 mg/0.8 ml
• Dosage Form: Injectable; injection
• Company: Sandoz Inc.
• Approval Date: October 30, 2018
• Submission Classification: Not Applicable
• Indication(s): Indicated for treatment of:
• Rheumatoid Arthritis (RA) (1.1): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. 
• Juvenile Idiopathic Arthritis (JIA) (1.2): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older. 
• Psoriatic Arthritis (PsA) (1.3): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA
• Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in adult patients with active AS. 
• Adult Crohn’s Disease (CD) (1.5): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. 
• Ulcerative Colitis (UC) (1.7): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HYRIMOZ has not been established in patients who have lost response to or were intolerant to TNF-blockers. 
• Plaque Psoriasis (Ps) (1.8): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. 
• Approved Label: 10/30/2018(PDF)