USFDA

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision on this investigational use is June 9, 2022.

Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application, Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 ml, Unit-dose Vials to market a generic equivalent of Brovana ® Inhalation Solution, 15 mcg /2 ml of Sunovion Pharmaceuticals Inc. (Sunovion).

The U.S. Food and Drug Administration has approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, the generic version of Ziac®1 Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, of Teva Branded Pharmaceutical Products R&D, Inc.

Marker Therapeutics, Inc a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the United States Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to MT-601, a multi-tumor-associated antigen (MultiTAA)-specific T cell product optimized for the treatment of patients with pancreatic cancer.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately $659.9 million*.

Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trintellix Tablets 5 mg, 10 mg, 15 mg, and 20 mg, of Takeda Pharmaceuticals, USA, Inc. (Takeda). Vortioxetine Tablets are indicated for the treatment of major depressive disorder (MDD).

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.