Generics Recently Launched
Dr. Reddy’s launches generics of Diovan and venlafaxine ER, Apotex launches generic atropine sulfate solution, and Teva launches generic of Epiduo Forte.
Teligent Initiates Third Recall of Lidocaine
The topical anesthetic was found to be “super potent,” which could lead to systemic toxicity and central nervous system and cardiovascular reactions.
FDA Approves Therapy for Multiple Sclerosis-Related Spasticity
The oral granules formulation allows it to be used with soft foods and with feeding tubes.
PharmaEssentia Launches Besremi for Rare Blood Disease
Besremi was approved in November to treat adults with polycythemia vera.
Amber Specialty is Chosen to Dispense Livtencity
Livtencity, manufactured by Takeda, was approved in November 2021 and is the first therapy to treat cytomegalovirus infection after transplants.
Gilead Recalls Two Lots of COVID-19 Therapy Veklury
Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.
Secura Bio Withdraws U.S. Oncology Indications for Copiktra, Farydak
Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.
Drug Shortages Update — December 5, 2021
Sandoz Recalls One Lot of Enoxaparin
A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.
FDA Accepts for Priority Review Supplemental Application of Reblozyl
The FDA is reviewing Reblozy to treat anemia in patients with beta thalassemia. The PDUFA action date is March 27, 2022.
FDA Approves Vaccine for Hepatitis B
PreHevBrio is a three-antigen hepatitis B vaccine for adults in the United States. It is expected to be available in the first quarter of 2022.
Merck Submits Application for Vaxneuvance for Children, Adolescents
The FDA has set a PDUFA action date of April 1, 2022.
FDA Accepts BMS Application for Psoriasis Therapy
The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.
Advisory Committee Recommends Authorization of the COVID-19 Anti-viral Molnupiravir
If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.
FDA Approves Imaging Agent to Detect Ovarian Cancer
Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.
Merck Releases Updated Data on its COVID-19 Antiviral
Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.
FDA Approves Treatment for Post-Transplant Infection
Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.
Recent Generic Launches
Several new generics have launched in the United States, including for the migraine therapy Zomig, the anticancer therapy Doxil, and an anti-inflammatory used to treat respiratory conditions associated with COVID-19.
FDA Accepts for Priority Review Gene Therapy for Rare Blood Disorder
If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.
Long-term Study Shows Pfizer COVID-19 Vaccine is 100% Effective in Adolescents
Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.
Sagent Recalls Four Lots of Levetiracetam
The antiseizure medication affected by the recall could have sterility issues.
Formulary Watch Drug Shortage Update — November 21, 2021
Gilead Submits BLA for Chronic Hepatitis Therapy
Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
FDA Approves First Drug for a Form of Dwarfism
BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.
FDA Expands EUA for Moderna and Pfizer COVID-19 Boosters
The boosters are now authorized for all people 18 years of age and older.
Onco360 Chosen as a Specialty Pharmacy Provider for Besremi
Besremi was approved recently to treat a rare blood disease.
FDA Grants Approval to Keytruda for Early Stage RCC
Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.
Pfizer Seeks EUA for COVID-19 Oral Antiviral
If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.
Biocon Launches Biosimilar Semglee
Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.
SterRx Recalls 240 Lots of 12 Products
Equipment and process issues could lead to a lack of sterility.
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