Mylan launches schizophrenia generic
PITTSBURGH — Mylan on Thursday today launched Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg and 16 mg in the United States. It is a generic version of the reference listed drug, Trilafon Tablets 2 mg, 4 mg, 8 mg and 16 mg, originally marketed by Schering.
Mylan previously received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for this product, which is used in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults.
Perphenazine Tablets USP, 2 mg, 4 mg, 8 mg, and 16 mg, had U.S. sales of approximately $41 million for the 12 months ending Feb. 28, according to IMS Health.
Currently, Mylan has 236 ANDAs pending FDA approval representing approximately $104.3 billion in annual brand sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2016.
Teva simultaneously launches AirDuo RespiClick and its authorized generic
JERUSALEM — Teva Pharmaceutical Industries on Thursday announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist (LABA) combination.
AirDuo RespiClick and its authorized generic are fixed-dose combination asthma therapies containing an ICS and a LABA, the same active ingredients as Advair. The authorized generic is known as fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler). Teva is launching both products at the same time in an effort to address the need for more affordable asthma treatment options in the U.S. Teva expects that sales of the authorized generic will represent most of the sales of the two products.
“With the launch of AirDuo RespiClick and its authorized generic, our intent is to meet the needs of patients, providers, and payers in the U.S. seeking greater access to lower-cost asthma inhaler technology, while also allowing Teva to compete in the highly competitive asthma combination controller market,” said Rob Koremans, M.D., president and CEO of Global Specialty Medicines at Teva. “This important launch marks not only the first available generic ICS/LABA product in the United States, but also the continued expansion of our RespiClick family of products, which now includes breath-activated inhaler options for both maintenance treatment and rescue medication.”
AirDuo RespiClick was approved by the Food and Drug Administration in January in three doses: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. AirDuo RespiClick contains medication delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler, which is used with other approved medicines in Teva’s respiratory product portfolio.