Original New Drug Application Approvals by US FDA (16 - 31 May 2022
31 May 2022
New drug applications approved by US FDA as of 16-31 May 2022 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.
CARMUSTINE
CARMUSTINE
- Active Ingredient(s): Carmustine
- Strength: 50MG/VIAL
- Dosage Form(s) / Route(s): Injectable;Injection
- Company: Accord Hlthcare Inc
- Approval Date: 16 May 2022
- Submission Classification: Type 2 - New Active Ingredient
- Indication(s): Indicated as palliative therapy as a single agent or in established combination therapy with other approved
chemotherapeutic agents in the following:
- Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors
- Multiple myeloma-in combination with prednisone
- Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs
- Relapsed or refractory non-Hodgkin's lymphomas in combination with other approved drugs
- Approved Label: 16 May 2022 (PDF)
- Active Ingredient(s): Tecovirimat
- Strength: 200MG/20ML (10MG/ML)
- Dosage Form(s) / Route(s): Solution;Intravenous
- Company: Siga Technologies
- Approval Date: 18 May 2022
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.
Limitations of Use:- The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical
- TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models
- Approved Label: 18 May 2022 (PDF)
- Active Ingredient(s): Treprostinil
- Strength: 16MCG
- Dosage Form(s) / Route(s): Powder;Inhalation
- Company: United Therap
- Approval Date: 23 May 2022
- Submission Classification: Type 5 - New Formulation or New Manufacturer
- Indication(s): Indicated for the treatment of:
- Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
- Approved Label: 23 May 2022 (PDF)
- Active Ingredient(s): Tapinarof
- Strength: 1%
- Dosage Form(s) / Route(s): Cream;Topical
- Company: Dermavant Sciences Inc
- Approval Date: 23 May 2022
- Submission Classification: Type 1 - New Molecular Entity
- Indication(s): Indicated for the topical treatment of plaque psoriasis in adults.
- Approved Label: 23 May 2022 (PDF)
- Active Ingredient(s): Pegfilgrastim-pbbk
- Strength: 6MG/0.6ML
- Dosage Form(s) / Route(s): Injectable;Injection
- Company: Kashiv Biosciences Llc
- Approval Date: 26 May 2022
- Submission Classification: NA
- Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use:
FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. - Approved Label: 26 May 2022 (PDF)