Posts in category: Uncategorized

Sunlenca approved by FDA for use with other antiretrovirals for the treatment of HIV-1 infections

Gilead Sciences, Inc. has announced that Sunlenca® (lenacapavir), in combination with other antiretroviral(s) (ARV), has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection.

Sunlenca belongs to a new class of drugs called capsid inhibitors and is designed to inhibit HIV-1 at
multiple stages of its lifecycle and may work against HIV strains that are resistant to other HIV drugs.
Sunlenca offers a new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen.

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The FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic
corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021.

Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients ages 2 to less than 18 years who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB).

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FDA Approves Tymlos as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture

Radius Health, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Tymlos (abaloparatide), a parathyroid hormone related peptide [PTHrP(1-34)] analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy.

Tymlos is a man-made form of parathyroid hormone that exists naturally in the body.

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FDA Approves Indication for Pemfexy in Combination with Pembrolizumab and Platinum Chemotherapy

Eagle Pharmaceuticals, Inc announced today that the U.S. Food and Drug
Administration has approved an additional indication for Pemfexy® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved Pemfexy (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

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FDA Approves Vraylar (cariprazine) as an Adjunctive Treatment for Major
Depressive Disorder

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Vraylar® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.

The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting,
indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness.

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Adstiladrin (nadofaragene firadenovec-vncg) suspension approved for intravesical use

Ferring Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin® (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing approximately 75% of all new bladder cancer cases. BCG remains the first-line standard of care for people living with high-grade NMIBC. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.

Adstiladrin, an intravesical therapy administered every three months, targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight cancer. The FDA approval was based on results of the Phase 3 clinical trial, which met its primary endpoint with more than half (51%, n=50 of 98; 95% CI 41 to 61) of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete response (CR) by three months. Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.

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ADMA Biologics Announces FDA Approval for Room Temperature Storage of Asceniv & Bivigam

ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental
Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to now include room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf
life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral
immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).

BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to, the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.

The newly approved room temperature storage labeling for ASCENIV and BIVIGAM is immediately effective, and product is commercially available to U.S. healthcare providers and patients.

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Epclusa is a brand name of sofosbuvir/velpatasvir. An authorized generic version of Epclusa has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

Sofosbuvir and velpatasvir is a combination antiviral medicine used to treat chronic hepatitis C in adults and children at least 3 years old.

List of authorized generic versions:

• Velpatasvir and Sofosbuvir ORAL TABLET, FILM COATED 400; 100 mg/1; mg Asegua Therapeutics LLC NDC Code: 726262701

Vanos topical propylene glycol Patent expiration date: January 7, 2023

• A generic version of Vanos has been approved by the FDA. The following products are equivalent to Vanos and have been approved by the FDA: Fluocinonide cream; topical
• Manufacturer: AMNEAL Approval date: June 4, 2018 Strength(s): 0.1% [AB]
• Manufacturer: CADILA Approval date: February 10, 2020 Strength(s): 0.1% [AB]
• Manufacturer: FOUGERA PHARMS INC Approval date: July 14, 2014 Strength(s): 0.1% [AB]
• Manufacturer: GLENMARK GENERICS Approval date: July 14, 2014 Strength(s): 0.1% [AB]
• Manufacturer: PADAGIS ISRAEL Approval date: January 14, 2014 Strength(s): 0.1% [AB]
• Manufacturer: PAI HOLDINGS PHARM Approval date: April 3, 2019 Strength(s): 0.1% [AB]
• Manufacturer: TARO Approval date: July 14, 2014 Strength(s): 0.1% [AB]

Symbicort budesonide/formoterol Patent expiration date:

• January 29, 2023 A generic version of Symbicort has been approved by the FDA. The following products are equivalent to Symbicort and have been approved by the FDA:
• For the treatment of asthma in patients 6 years of age and older
• For reducing exacerbations of chronic obstructive pulmonary disease
• For maintenance treatment of chronic obstructive pulmonary disease Breyna Generic name: budesonide and formoterol fumarate Dosage form: aerosol, metered.
• Read more… https://www.drugs.com/news/first-symbicort-receives-fda-approval-104726.html