All posts by : Admin

Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The additional lots were distributed October 26, 2021 through April 25, 2022.

• The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. There is a potential of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury. Within the sixty-three (63) total recalled lots (which includes more than 2.7 million vials), Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts.
• Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
• Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-3321088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.
• View the full recall notice on the U.S. FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciencesllc-expands-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50

Global biotechnology leader CSL (ASX: CSL) has announced that the U.S. Food and Drug Administration (FDA) approved Hemgenix (etranacogene dezaparvovec-drlb), the first and only onetime gene therapy for appropriate adults with hemophilia B.

• Hemgenix is approved for the treatment of adults with hemophilia B who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes.
• Hemgenix®, etranacogene dezaparvovec-drlb is administered as a single intravenous infusion and can be administered only once.
• In the ongoing clinical trial, Hemgenix reduced the rate of annual bleeds and 94 percent of patients discontinued factor IX prophylaxis and remained prophylaxis-free.
• If you have preexisting risk factors for liver cancer, regular liver health testing will continue for 5 years post-administration. Treatment for elevated liver enzymes could include corticosteroids.
• The most common side effects reported in more than 5% of patients were liver enzyme elevations, headache, elevated levels of a certain blood enzyme, flu-like symptoms, infusion-related reactions, fatigue, nausea, and feeling unwell.
• Read more… https://www.drugs.com/newdrugs/fda-approves-hemgenix-etranacogene-dezaparvovec-drlb-genetherapy-hemophilia-b-5931.html Tzield November 17, 2022 – Provention Bio, Inc. (Nasdaq: PRVB),

FDA Approves Monday/Wednesday/Friday Intramuscular Dosing Schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing
schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn). Rylaze is approved for use in the U.S. as a component of a multi-agent chemotherapeutic regimen for the treatment of acute
lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.

When first approved in the U.S. in June 2021, under the FDA Real-Time Oncology Review (RTOR) program, the approval had a dosing schedule of 25 mg/m2 administered IM every 48 hours met the
immediate patient need for a non-E.coli-derived asparaginase treatment option while the clinical trial was still ongoing to evaluate additional dosing and administration options.

Read more…

Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration has approved Sezaby™ (phenobarbital sodium powder for injection) for the treatment of neonatal seizures.

• With this approval, Sezaby becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. Sezaby is expected to be available in the U.S. in Q4FY23.
• Sezaby is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the US FDA for the treatment of neonatal seizures.
• Sezaby was recently licensed by SPARC to Sun Pharma. Under the terms of the license agreement, SPARC is eligible to receive a milestone payment on approval of Sezaby by the US FDA.
• Read more… https://www.drugs.com/newdrugs/fda-approves-sezaby-phenobarbital-sodium-powder-neonatalseizures-5932.html

Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, has announced that the United States Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for Tzield (teplizumab-mzwv), an anti-CD3-directed antibody, for intravenous use, as the first and only immunomodulatory treatment to delay the onset of Stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 T1D.

• TZIELD injection is supplied as a sterile, preservative-free, clear, and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. TZIELD should be administered by intravenous infusion (over a minimum of 30 minutes) once daily for 14 days.
• TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections.
• The most common adverse reactions (>10%) that occurred during treatment and through 28 days after the last study drug administration from the TN-10 study were lymphopenia), rash, leukopenia and headache.
• Read more… https://www.drugs.com/history/tzield.html

Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands Similac® Pro-Total ComfortTM, Similac® 360 Total Care®, Similac 360 Total Care Sensitive, Similac® Special Care® 24, Similac Stage 1, Similac® NeoSure®, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. The products included in the recall were manufactured at our Columbus, Ohio manufacturing facility.

These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.

Jiangsu Well Biotech Co., Ltd. is recalling COVID-19 Ag Rapid Test Devices because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. The company has not provided the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

There is also a risk of injury if users follow any labeling instructions directing self-collection of nasopharyngeal or oropharyngeal samples.

There have been no complaints or reports of injuries or deaths.

Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved Medicines360’s Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta® (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years. This approval is based on data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) that Medicines360 first published in the American Journal of Obstetrics and Gynecology in May 2022. With this FDA approval, Liletta has one of the longest approved durations of use for a hormonal intrauterine device (IUD or IUS) in the U.S. Originally approved by the FDA on February 26, 2015, Liletta (levonorgestrel) is a hormonal intrauterine device (IUD) for use by women to prevent pregnancy for up to eight years.

• Read more… FDA Approves Medicines360’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years

Manufacturer ImmunoGen, Inc., has announced that Elahere™ (mirvetuximab soravtansine-gynx) has been approved as a folate receptor alpha (FRα)-directed antibody and microtubule 4 Drug News – Volume 9, Issue 12 inhibitor conjugate indicated for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

• Elahere is an intravenous infusion administered once every 3 weeks (21-day cycle). Dosage is based on each patient’s ideal body weight.
• ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
• It is not known if this medicine is safe and effective in children. • Read more… https://www.drugs.com/pro/elahere-injection.html#s-43685

Seagen Inc. (Nasdaq: SGEN) has announced that the U.S. Food and Drug Administration (FDA) has approved Adcetris® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. Originally approved by the FDA on August 19, 2011, Adcetris (brentuximab vedotin) injection is a CD30directed antibody-drug conjugate (ADC) used for the treatment of Hodgkin lymphoma, anaplastic large cell lymphoma, and mycosis fungoides. 5 Drug News – Volume 9, Issue 12

• Read more… Seagen Announces U.S. FDA Approval of New Indication for Adcetris (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma