Recalls and warnings
A recall of one lot of paliperidone extended-release tablets (3 mg, 90-count bottles) due to failed test results for dissolution. Subtherapeutic levels could occur if patients with schizophrenia and schizoaffective disorders take two or more consecutive dosing regimens with affected tablets. The probability of this is low, and no related adverse events have been reported, according to the manufacturer's investigation.
A recall of one lot of apixaban (Eliquis) 5-mg tablets to the retail/dispensing level due to a customer complaint that a bottle contained 2.5-mg tablets. Recalled products were distributed in February 2017.
A recall of batches of NovoPen Echo insulin cartridge holders that may crack or break if exposed to certain chemicals, such as cleaning agents. Affected products were distributed between Aug. 1, 2016, and June 22, 2017. The manufacturer has corrected the problem and is providing replacement cartridge holders for affected consumers.
Voxilaprevir in combination with sofosbuvir and velpatasvir (Vosevi) to treat adults with chronic hepatitis C virus (HCV) genotypes 1 through 6 who have mild or no cirrhosis. The fixed-dose tablet is the first treatment approved for patients previously treated with sofosbuvir or other HCV drugs that inhibit nonstructural protein 5A (NS5A). Safety and efficacy were tested in two clinical trials of about 750 adults with mild or no cirrhosis. Overall, 96% to 97% of patients who took the new combination drug had no virus detected in their blood 12 weeks after completing treatment. Due to concerns about hepatitis B virus (HBV) reactivation in co-infected patients, clinicians should screen for current or prior HBV infection before starting treatment with the new drug. The most common adverse reactions were headache, fatigue, diarrhea, and nausea. The drug is contraindicated in patients taking rifampin.
L-glutamine oral powder (Endari) to reduce severe complications associated with sickle cell disease. The orphan drug's safety and efficacy were evaluated in a randomized, placebo-controlled trial of patients ages 5 to 58 years with sickle cell disease and two or more painful crises within the previous 12 months. Over 48 weeks of follow-up, treated patients had fewer sickle cell crises on average than those who received placebo (median, three vs. four), as well as fewer hospitalizations for sickle cell pain (median, two vs. three) and fewer days in the hospital (median, 6.5 days vs. 11 days). Patients who received the drug also had fewer occurrences of acute chest syndrome compared with those who received placebo (8.6% vs. 23.1%). Common side effects include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain, and chest pain.
Haegarda to prevent hereditary angioedema attacks in adolescent and adult patients. The orphan drug, a C1 esterase inhibitor derived from human plasma, is administered subcutaneously by the patient or caregiver after proper training. It is indicated for routine prophylaxis, not to treat acute attacks. Efficacy was demonstrated in a multicenter controlled trial of 90 patients ages 12 to 72 years with symptomatic disease. Participants were randomized to receive two weekly subcutaneous doses of 40 IU/kg or 60 IU/kg. During 16 weeks of treatment, both doses were associated with a significantly reduced number of attacks versus placebo periods in the same patients. The most common side effects were injection-site reactions, hypersensitivity reactions, nasopharyngitis, and dizziness. The drug should not be used in patients who have had life-threatening hypersensitivity reactions to a C1 esterase inhibitor preparation or its inactive ingredients.
First-time generic approvals
Atomoxetine capsules USP (10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg) to treat attention-deficit/hyperactivity disorder. (Brand name: Strattera)
Doxycycline hyclate tablets USP (75 mg, 150 mg) to treat rickettsial, sexually transmitted, respiratory tract, ophthalmic, and specific bacterial infections; to treat anthrax, including inhalational anthrax (post-exposure); as an alternative treatment for certain infections when penicillin is contraindicated; as adjunctive therapy for acute intestinal amebiasis and severe acne; and as prophylaxis of malaria. (Brand name: Acticlate)
Emtricitabine and tenofovir disoproxil fumarate tablets (200 mg/300 mg) combined with other antiretroviral agents to treat HIV-1 infection and in combination with safer sex practices as pre-exposure prophylaxis to prevent sexually acquired HIV infection in high-risk adults. (Brand name: Truvada)
Mesalamine delayed-release tablets USP (1.2 g) to induce and to maintain remission in ulcerative colitis. (Brand name: Lialda)
Paroxetine capsules (7.5 mg) for moderate to severe vasomotor symptoms associated with menopause. (Brand name: Brisdelle)
Phentermine hydrochloride orally disintegrating tablets (15 mg, 30 mg, 37.5 mg) as a short-term adjunct to manage exogenous obesity for certain patients as part of a weight-reduction regimen. (Brand name: Suprenza)
Prasugrel tablets (5 mg, 10 mg) to reduce thrombotic cardiovascular events in certain patients with acute coronary syndrome managed with percutaneous coronary intervention. (Brand name: Effient)
Rosiglitazone maleate and metformin hydrochloride tablets (1 mg [base]/500 mg) to improve glycemic control in type 2 diabetes as an adjunct to diet and exercise. (Brand name: Avandamet)
Sevelamer carbonate powder for oral suspension (0.8 g, 2.4 g) to control serum phosphorus in adults with chronic kidney disease on dialysis. (Brand name: Renvela).
Note: The FDA states that drugs are not always commercially available immediately after approval.