Monthly Archives: December 2022

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.

Read more…

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

Legalization of medical marijuana is associated with a reduction in opioid dispensing and pain-related hospital events among adults receiving treatment for newly diagnosed cancers, according to a study published online Dec. 1 in JAMA Oncology.

Yuhua Bao, Ph.D., from Weill Cornell Medicine in New York City, and colleagues conducted a crosssectional study using 2012 to 2017 national commercial claims data and a difference-in-differences design to examine the association between medical marijuana legalization that took effect between 2012 and 2017 and opioid-related and pain-related outcomes for patients receiving cancer treatment. Data were included for 38,189 patients newly diagnosed with breast cancer (100 percent women); 12,816 with colorectal cancer (55.4 percent men); and 7,190 with lung cancer (51.1 percent women).

The researchers found that medical marijuana legalization was associated with a reduction in the rate of one or more opioid days among patients with breast cancer with recent opioids, with colorectal cancer with recent opioids, and with lung cancer without recent opioids (difference, 5.6, 4.9, and 6.5 percentage points, respectively). Among patients with lung cancer with recent opioids, legalization of medical marijuana was associated with a reduction in the rate of one or more pain-related hospital events (difference, 6.3 percentage points).

“The findings suggest that medical marijuana could be serving as a substitute for opioids to some extent,” the authors write. “Future studies need to elucidate the nature of the associations and their implications for patient outcomes.”

Herpes zoster (HZ) is associated with an elevated long-term risk for a cardiovascular event, according to a study published online Nov. 16 in the Journal of the American Heart Association.

Sharon G. Curhan, M.D., from Brigham and Women’s Hospital in Boston, and colleagues examined the longitudinal association of HZ and long-term risk for stroke or coronary heart disease (CHD) among 79,658 women in the Nurses’ Health Study (NHS), 93,932 women in the NHS II, and 31,440 men in the Health Professionals Follow-Up Study.

The researchers found that 3,603 incident stroke and 8,620 incident CHD cases were documented during >2 million person-years of follow-up. There was a significant and independent association observed for history of HZ with higher long-term risk for stroke and CHD. Compared with those with no history of HZ, the multivariable-adjusted hazard ratios (95 percent confidence intervals) for stroke were 1.05 (0.88 to 1.25), 1.38 (1.10 to 1.74), 1.28 (1.03 to 1.59), and 1.19 (0.90 to 1.56) among those with one to four, five to eight, nine to 12, and 13 or more years since HZ, respectively. The corresponding multivariableadjus ted hazard ratios (95 percent confidence intervals) for CHD were 1.13 (1.01 to 1.27), 1.16 (1.02 to 1.32), 1.25 (1.07 to 1.46), and 1.00 (0.83 to 1.12) for one to four, five to eight, nine to 12, and 13 or more years since HZ.

“These findings suggest there are longterm implications of HZ and underscore the importance of public health efforts for prevention,” the authors write.

Several authors disclosed financial ties to pharmaceutical and medical technology companies, including GlaxoSmithKline Biologicals, which partially funded the study.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezlidhia (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

• Rezlidhia is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells.
• Rezlidhia is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
• “Given the limited treatment options for adult patients with mIDH1 R/R AML, who typically have a poor prognosis, Rezlidhia may provide an effective, new treatment option with a well characterized safety profile” said Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.
• Read more… https://www.drugs.com/rebyota.html