Isradipine (DynaCirc - Sandoz), a dihydropyridine calcium-channel blocker chemically related to nicardipine (Cardene) and nifedipine (Procardia, and others), was recently approved by the US Food and Drug Administration for oral treatment of hypertension.

(Ceredase - Genzyme) a modified form of the glycoprotein enzyme glucocerebrosidase prepared from human placenta, was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of patients with the non-neurologic form of Gaucher's disease (Type 1).

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

Breaking drug tablets in half is a common practice. Since our last article on this subject, some new data have become available.

The US Advisory Committee on Immunization Practices (ACIP) has recommended that adults with immunocompromising conditions receive the 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13), even if they have already received the older 23-valent unconjugated vaccine (PPSV23; Pneumovax 23). Prevnar 13, initially approved by the FDA for use in infants and young children, has been licensed since December 2011 for adults ≥50 years old.

The FDA has required manufacturers of the oral P2Y₁₂ platelet inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta) to warn in the product labels that the absorption of these drugs may be delayed or reduced when taken with an opioid agonist.

The FDA has approved tafamidis, an oral transthyretin stabilizer, in 2 different formulations (see Table 1) for treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). Tafamidis is the first drug to be approved in the US for this indication. Patisiran (Onpattro), a transthyretin-directed small interfering RNA, and inotersen (Tegsedi), a transthyretin-directed antisense oligonucleotide, were both recently approved for hereditary transthyretin amyloid polyneuropathy.THE DISEASE — ATTR-CM is a progressive life-threatening disease caused by destabilization of the...

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.

Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation. It is the second drug that targets cancer metabolism to be approved for this indication; ivosidenib (Tibsovo) was approved in 2022.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.