The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.

The tissue plasminogen activator (tPA) tenecteplase (TNKase – Genentech) has been approved by the FDA for treatment of acute ischemic stroke in adults. It is the second tPA to be approved in the US for this indication; alteplase (Activase) was approved in 1996. Tenecteplase was approved in 2000 to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI).

As cocaine continues to be widely available in the USA (Medical Letter, 28:69, 1986), new problems associated with its use continue to emerge. Some recent reports indicate that use of the drug during pregnancy can damage the fetus, lead to abortion or premature labor, and cause toxic effects in the newborn infant.

The NovolinPen (Squibb - Novo) is a device that uses prefilled cartridges to inject semisynthetic human insulin (Medical Letter, 25:63, 1983). Three formulations are available: regular insulin (Novolin R PenFill), NPH insulin isophane (Novolin N PenFill) and a mixture of 70% NPH and 30% regular (Novolin 70/30 PenFill). The NovolinPen is advertised as more accurate, more convenient and less expensive than conventional syringes and needles. The same device is marketed in Canada as the Novolin-Pen II (Connaught Novo). (An earlier device is also available as the Novolin-Pen in Canada and the...

Dezocine (Dalgan - Astra), a new synthetic opioid agonist/antagonist structurally related to pentazocine (Talwin), was recently approved for parenteral use as an analgesic by the US Food and Drug Administration.

Pegaspargase (peg as par jase; PEG-L-asparaginase; Oncaspar - Rh ne-Poulenc Rorer), a polyethylene glycol (PEG) conjugate of L-asparaginase, has been approved by the US Food and Drug Administration for treatment of acute lymphoblastic leukemia (ALL), the most common malignancy of childhood. The new drug is recommended only for patients who have had allergic reactions to asparaginase. Asparaginase is available commercially as Elspar, which is derived from Escherichia coli. A formulation derived from Erwinia chrysanthemi is available on an investigational basis (Ogden Bioservices,...

Abciximab (ab sik si mab; ReoPro - Centocor), the Fab (fragment antigen binding) fragment of the chimeric human-murine monoclonal antibody 7E3 (c7E3 Fab), has been approved by the US Food and Drug Administration as an adjunct to percutaneous transluminal coronary angioplasty or atherectomy (PTCA) to prevent abrupt closure of the treated coronary vessel.

Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

Ibutilide fumarate (Corvert - Pharmacia & Upjohn), a new antiarrhythmic drug for intravenous use, has been approved by the US Food and Drug Administration for acute termination of atrial fibrillation or flutter of recent onset.

Glatiramer acetate (Copaxone - Teva Marion Partners), formerly known as copolymer-l, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (MS). Interferon β-1b (Betaseron) and interferon β-1a (Avonex - Medical Letter, 38:63, 1996) were previously approved for this indication.