The FDA has approved the ophthalmic solutions riboflavin 5'-phosphate in 20% dextran (Photrexa Viscous – Avedro) and riboflavin 5'-phosphate alone (Photrexa) for use with ultraviolet A (UVA) light (KXL System) in the corneal collagen cross-linking treatment of two corneal disorders: progressive keratoconus and corneal ectasia following refractive surgery. It is the first corneal collagen cross-linking (CXL) treatment to be approved by the FDA.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

The oral second-generation antipsychotic drug iloperidone (Fanapt – Vanda) has been approved by the FDA for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. First approved in 2009 for treatment of schizophrenia, iloperidone is the eighth second-generation antipsychotic to be approved for acute treatment of manic or mixed episodes of bipolar I disorder (see Table 1).

Eszopiclone (Lunesta - Sepracor), a benzodiazepine-like drug, has been approved by the FDA for oral treatment of insomnia. It is the S-isomer of zopiclone (Imovane, and others in Canada), which has been available in other countries for almost 20 years. Unlike similar drugs such as zolpidem (Ambien) or zaleplon (Sonata), Lunesta is not being restricted in its labeling to short-term use. Like other hypnotics, eszopiclone is a schedule IV drug.

Exenatide injection (Byetta - Amylin/Lilly), a synthetic peptide that stimulates release of insulin from pancreatic beta cells, has been approved by the FDA as adjunctive therapy for patients with type 2 diabetes who have not achieved optimal glycemic control on metformin (Glucophage, and others), a sulfonylurea, such as glyburide (DiaBeta, and others), or both. Exenatide is not indicated for use with insulin.

Many patients ask their physicians whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamin supplements.

Ramelteon (Rozerem - Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.

Avandaryl, a new fixed-dose tablet combining the thiazolidinedione rosiglitazone (Avandia) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved for patients already taking a combination of rosiglitazone and a sulfonylurea or those not adequately controlled on rosiglitazone or sulfonylurea monotherapy. Rosiglitazone is also available in a fixed-dose combination with metformin (Avandamet). Most patients with type 2 diabetes eventually require 2 drugs with different mechanisms to control...

Lisdexamfetamine dimesylate (Vyvanse - Shire), a prodrug in which d-amphetamine is covalently bonded to L-lysine, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years old. It was designed to have less potential than amphetamine itself for abuse, diversion or overdose toxicity. Like methylphenidate and amphetamines, lisdexamfetamine is a Schedule II controlled substance.

The FDA has approved a transmucosal tablet formulation of fentanyl citrate (Fentora - Cephalon) for management of breakthrough pain in opioid-tolerant patients with cancer. An oral transmucosal fentanyl lozenge on a stick (Actiq, and others) is also available for this indication, and is widely used off-label for chronic, non-cancer pain as well.