Generics

PEAPACK, N.J. — Greenstone on Friday announced the introduction of its authorized generic of Tikosyn (dofetilide) capsules. The drug is indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week who have been converted to normal sinus rhythm. 

 

Greenstone's dofetilide will be available in 60-count bottles of 0.125-, 0.250- and 0.5-mg dosage strength capsules.

 

SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo Pharma’s generic version of Dilaudid (hydromorphone HCl) tablets, the company announced Wednesday. The drug is indicated to relieve moderate to severe acute pain in patients for whom opioid use is appropriate. 

 

Aurobindo’s hydromorphone tablets will be available in 2-, 4- and 8-mg dosage strengths. The product had an estimated market size of $49.3 million fo the 12 months ended April 2016, according to IMS Health. 

 

SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s U.S. subsidiary Gavis’ generic Vfend (voriconazole), the company announced Monday. The drug is indicated to treat invasive aspergillosis, esophageal candidiasis and other serious invasive fungal infections. 

 

PITTSBURGH — Mylan on Friday launched its generic of Cleocin (clindamycin palmitate hydrochloride) solution. The drug is indicated to treat serious infections caused by susceptible anaerobic bacteria and susceptible strains of streptococci, pneumococci and staphylococci when less toxic alternatives aren’t appropriate. 

 

The product had U.S. sales of about $30.9 billion for the 12 months ended March 31, according to IMS Health. Mylan’s generic will be available as a 75 mg/5 mL oral solution. 

 

NORTH WALES, Pa. — Teva Pharmaceuticals on Thursday announced the launch of its generic Lescol XL (fluvastatin sodium) extended-release tablets. The drug is indicated to treat high cholesterol and triglycerides. 

 

“Our customers count on Teva for a continuous supply of new generic products,” Teva SVP and general manager U.S. generics Maureen Cavanaugh said. “With the launch of Fluvastatin Sodium Extended-Release Tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”

PITTSBURGH — Mylan on Thursday launched two new generic products. The company rolled out its generic of Celgene’s Vidaza (azacitidine, 100 mg/vial) injection and its generic of GSK’s Rhythmol (propafenone HCl) extended-release capsules. 

 

PITTSBURGH — Mylan has launched the first generic version of Cephalon’s Nuvigil (armodafinil) tablets, which entitles the company to 180 days of market exclusivity. The drug is indicated to improve wakefulness in adults with excessive sleepiness associated with sleep apnea, narcolepsy or shift-work disorder. 

 

Mylan’s armodafinil will be available in 50-, 150- and 250-mg dosage strengths. The drug had sales of about $489.7 million for the 12 months ended March 31, according to IMS Health.