The product was designed using the Amphastar’s proprietary nasal delivery device.
The approval was based on data from a phase 3 study which included adults with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper.
The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection.
Belimumab is a B-lymphocyte stimulator-specific inhibitor.
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
OPNT003 is an intranasal formulation containing the high affinity opioid antagonist, nalmefene.
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
The 20vPnC vaccine consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13, along with 7 additional serotypes that cause invasive pneumococcal disease.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
The issue appears to be related to the availability of generic oseltamivir.
The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021.
The bivalent formulations contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
According to a long-term safety study and a separate FDA internal study, Prolia had an increased risk of hypocalcemia in patients with advanced kidney disease on dialysis.
For regions with high levels of RSV disease activity in the fall and winter, the AAP supports the use of more than 5 consecutive doses of palivizumab to eligible infants.
These dietary supplements have not been evaluated by the FDA for safety or effectiveness.
Bebtelovimab is currently authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
Kineret is an interleukin-1 receptor antagonist.
The 2022 CDC Clinical Practice Guideline is intended to help clinicians weigh the benefits and risks of opioids and alternative pain treatments for outpatients.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
The approval was based on data from the SELECT-AXIS 2 trial that included adults with active nr-axSpA who had an inadequate response or intolerance to TNF blocker therapy.
Findings showed that the booster dose elicited robust antibody responses comparable to, or exceeding levels associated with the efficacy data in the primary series of the vaccine.
The approval is supported by evidence from adequate and well-controlled studies of Stelara.
Interim results from the phase 1/2 COV001 trial evaluating the vaccine candidate ChAdOx1 nCoV-19 (AZD1222) showed that vaccination led to strong immune responses.
