New products for pharmacists 01-10-2016



New drugs

Last month, FDA has granted final approval to Basaglar, an insulin glargine injection (Eli Lilly and Company), which is a long-acting human insulin analog with an identical amino acid sequence to Lantus (sanofi-aventis). The insulin can be used for glycemic control in adults and children with type 1 diabetes and in adults with type 2 diabetes. FDA had tentatively approved Basaglar in August 2014, contingent upon patent litigation resolution. Basaglar will be available Dec. 15, 2016. (

In December, lesinurad (Zurampic), manufactured by AstraZeneca Pharmaceuticals, was approved for the treatment of hyperuricemia associated with gout, when used in combination with a xanthine oxidase inhibitor. According to the FDA, Zurampic helps the kidneys excrete uric acid by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidneys. Zurampic carries a boxed warning about the risk for acute renal failure, which is more common when used with a xanthine oxidase inhibitor and with higher than approved doses of Zurampic. A postmarketing study is required to evaluate the renal and cardiovascular safety of the drug. (

Another new agent that gained FDA approval last month was selexipag (Uptravi), a first-in-class selective agonist of prostacyclin IP receptor, which may improve the long-term outcomes of patients with pulmonary arterial hypertension (WHO Group 1). FDA approved Uptravi to delay the progression of PAH and reduce risk of related hospitalization, according to its manufacturer, Actelion. The drug is expected to be available early this month. (

Also in December, FDA approved sugammadex injection (Bridion, Merck) for the reversal of moderate or deep neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults during surgery. Bridion binds to the two neuromuscular blocking agents, which are used during endotracheal intubation and mechanical ventilation during surgery, and reverses paralysis induced by the two drugs. "Bridion provides a new treatment option that may help patients recover sooner from medications used for intubation or ventilation during surgery," Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research, in a press release. (

Otonomy announced last month that FDA has approved its antibacterial drug, Otiprio, for the treatment of pediatric patients with bilateral otitis media with effusion who are undergoing surgery to drain the fluid from the ear. Otitis media with effusion occurs when non-infected fluid accumulates in the middle ear, due to cold, sore throat or upper respiratory infection. The antibacterial agent will be available in the first quarter of this year. (


Last month, Allergan announced the availability of eluxadoline (Viberzi), an oral medication indicated for adults to relieve the diarrhea and abdominal pain associated with irritable bowel syndrome with diarrhea. “We are excited about the launch of Viberzi, which addresses an unmet need among IBS-D patients seeking a treatment to manage their symptoms proactively,” said William Meury, president and EVP, Branded Pharma at Allergan. “This introduction reaffirms Allergan’s commitment to providing a new treatment option that serves to help gastroenterologists reach better outcomes for their patients.” Viberzi is a Schedule IV controlled substance. (

Takeda also announced that ixazomib (Ninlaro), which was FDA approved in November, is available for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one previous therapy. Ninlaro was the first approved oral proteasome inhibitor that received priority review and orphan drug status. Ninlaro is available through an open distribution model that includes physician in-office dispensing.  Additionally, there is a specialty pharmacy network to assist patients and healthcare providers. (

In December, FDA updated the pembrolizumab (Keytruda) label to include the initial treatment of patients with unresectable or metastatic melanoma. In 2014, FDA had approved Keytruda for patients with unresectable or metastatic melaonoma and disease progression after treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Two new clinical trials provide evidence of clinical benefit of Keytruda for advanced melanoma, according to the FDA. (

New generics

Last month, Camber Pharmaceuticals announced the launch of linezolid 600-mg tablets, the generic version of Pfizer's Zyvox, which is indicated for the treatment of different types of bacterial infections, such as pneumonia, skin infections, and infections that are resistant to other antibiotics. Linezolid is available in 20- and 30-count bottles. Glenmark Pharmaceuticals also announced final approval of its linezolid 600-mg tablets in December. (

Camber Pharma has also launched its generic version of Prozac (fluoxetine), which is indicated for the treatment of major depression, bulimia nervosa, obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder. The company said that the generic drug will be available in doses of 10, 20, and 40 mg strength, and all of the doses will come in 30- or 100-count bottles. (

Camber also launched its generic versions of Merck's Cozaar (losartan potassium) tablets for the treatment of high blood pressure. The company noted that the tablets will be available in doses of 25, 50, and 100 mg strength. The 25-mg tablets will be available in 90-, 500-, and 1,000-count bottles, and the 50-mg and 100-mg tablets will come in bottles of 90 and 1,000. (


Heritage Pharmaceuticals announced last month the availability of verapamil 40-mg immediate-release tablets, the AB-rated generic equivalent to the calcium channel blocker drug Calan. The drug is used for the treatment of angina, arrhythmias, and essential hypertension. Heritage also has two other strengths of verapamil (80 and 120 mg). (

In December, FDA has given final approval to Aurobindo Pharma for olopatadine hydrochloride ophthalmic solution USP,  0.1%, which is therapeutically equivalent to the reference product, Alcon's Patanol ophthalmic solution/drops. The ophthalmic solution is used to treat ocular itching associated with allergic conjunctivitis. In November, FDA approved Aurobindo Pharma's generic version of risedronate sodium tablets, which are used for the treatment of osteoporosis. (

Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries received approval for its generic version of Novartis' Gleevec (imatinib mesylate) tablets, 100 and 400 mg strength. The Sun Pharma subsidiary may launch its generic product in February 2016, with 180-day exclusivity in the United States. (

Amneal Pharmaceuticals introduced its new lidocaine 5% ointment in December. The topical medication is available in a 35.44-g tube with a child-resistant cap and in a 50-g jar. The company also announced last month that it will launch a transdermal patch formulation following FDA approval. (

In December, Ajanta Pharma USA, a subsidiary of Ajanta Pharma Limited, India, launched its generic versions of Singulair (montelukast sodium IR tablets [10 mg]) and Singulair Chewable Tablets (4 mg and 5 mg). (

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