Formulary Watch

Dr. Reddy’s launches generics of Diovan and venlafaxine ER, Apotex launches generic atropine sulfate solution, and Teva launches generic of Epiduo Forte.

The topical anesthetic was found to be “super potent,” which could lead to systemic toxicity and central nervous system and cardiovascular reactions.

The oral granules formulation allows it to be used with soft foods and with feeding tubes.

Besremi was approved in November to treat adults with polycythemia vera.

Livtencity, manufactured by Takeda, was approved in November 2021 and is the first therapy to treat cytomegalovirus infection after transplants.

Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.

Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.

The FDA is reviewing Reblozy to treat anemia in patients with beta thalassemia. The PDUFA action date is March 27, 2022.

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.

The FDA has set a PDUFA action date of April 1, 2022.

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.

If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.

Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.

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.

Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.

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.

If approved, Bluebird Bio’s beti-cel would be the first one-therapy for β-thalassemia. The PDUFA date is May 20, 2022.

Pfizer/BioNTech plan to use this data to support submissions for full approval of the vaccine in those 12 to 15 years old.

The antiseizure medication affected by the recall could have sterility issues.

Bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.

BioMarin’s Voxzogo is expected to be available in the United States by mid- to late-December.

The boosters are now authorized for all people 18 years of age and older.

Besremi was approved recently to treat a rare blood disease.

Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.

If authorized, Paxlovid would be the first oral 3CL protease inhibitor specifically designed to combat the virus that causes COVID-19.

Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.

Equipment and process issues could lead to a lack of sterility.