The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
All articles by Brian Park, PharmD
The sBLA is supported by data from Studies A and B of phase 3 LIBERTY-CUPID trial which included patients with CSU who were inadequately controlled on standard-of-care H1 antihistamines.
While not approved for human use, xylazine has been detected in combination with opioids (eg, illicit fentanyl), and with stimulants (eg, methamphetamine, cocaine).
The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.
The designation is supported by data from the ongoing phase 2 KEYNOTE-942 study, which included 157 patients with stage III/IV melanoma following complete resection.
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor.
Narcan Nasal Spray is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
Sibutramine is a controlled substance that was voluntarily withdrawn from the market in October 2010.
The approval was based on data from previous studies that included 124 adolescent patients, as well as the phase 3 JADE TEEN study.
The letters cite violations related to drug misbranding failing to bear adequate directions for their intended use(s).
Amjevita is supplied as a 40 mg/0.8 mL single-dose prefilled SureClick autoinjector, and as 20 mg/0.4 mL and 40 mg/0.8 mL single-dose prefilled syringes.
Diclofenac epolamine topical system is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes.
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
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 INTEGUMENT-2 trial included patients 6 years of age and older with mild to moderate atopic dermatitis involving at least 3% body surface area.
The issue appears to be related to the availability of generic oseltamivir.
The BE HEARD I and BE HEARD II studies included more than 1000 adults with moderate to severe hidradenitis suppurativa.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
The CDC Nowcast data show that as of last week the BQ.1 and BQ.1.1 subvariants accounted for more than 57% of COVID-19 cases.
The trial compared Spravato (esketamine nasal spray) to quetiapine extended-release, both in combination with a continuing SSRI or SNRI.
Bebtelovimab is currently authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
Dupixent single-dose prefilled pens feature a hidden needle and single-press auto-injection.
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 was based on data from the phase 3 PRIME and PRIME2 trials.
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
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