Lupin closed 2016 with 3 tentative generic approvals
SILVER SPRING, Md. — The Food and Drug Administration handed out three tentative generic approvals to Lupin in the last week of 2016, the company announced. The company received tentative approval for its generics of Benicar (olemsartan medoximil) tablets), Giazo (balasalazide disodium) tablets and Livalo (pitavastatin) tablets.
The company’s generic of Daiichi Sankyo’s Benicar, which is indicated to treat hypertension, will be available in 20- and 40-mg dosage strengths. The drug had U.S. sales of $1.06 billion for the 12 months ended September 2016, according to QuintilesIMS data.
The Giazo generic will be available in 1.1-gram tablets, and the drug, for the treatment of mildly to moderately active ulcerative colitis in men aged 18 years and older, had U.S. sales of 0.79 million for the 12 months ended September 2016, according to QuintilesIMS data.
The company’s generic of Kowa’s Livalo tablets will be available in 1-. 2- and 4-mg dosage strengths. The drug is indicated to help lower total and LDL cholesterol while increasing HDL cholesterol and had U.S. sales of $245.3 million for the 12 months ended September 2016.
FDA approves 3 Teligent topical generics
SILVER SPRING, Md. — The Food and Drug Administration approved three generics from New Jersey-based specialty generics company Teligent on the last day of 2016, the company announced Tuesday.
The approvals were for the company’s generics of triamcinolone acetonide ointment, 1000,000 units/gram and 1mg/gram; clindamycin phosphate topical solution 1%; and flurandrenolide ointment, 0.05%.
The company said that this brings its portfolio of internally developed topical generics that received approval in 2016 to nine, and that the three products approved have an addressable market of about $73.6 million.
Mylan launches 3 generics
HERTFORDSHIRE, England and PITTSBURGH — Mylan last week capped off its 2016 by with the launch of three generics. The company on Thursday announced the launch of its generics of Concerta (methylphenidate hydrochloride) extended-release tablets, Zovia (ethynodiol diacetate and ethinyl estradiol, 1 mg/0.05 mg) tablets and Cerebyx (fosphenytoin sodium, 75 mg/mL) injection.
Mylan’s generic of Concerta, a drug indicated to treat attention deficit hyperactivity disorder, will be available in 18-, 27-, 36- and 54-mg dosage strengths. The drug had U.S. sales of about $1.59 billion for the 12 months ended Oct. 31, 2016, according to QuintilesIMS data. The company did not include sales information for its generic of Zovia, an oral contraceptive.
Mylan’s generic Cerebyx, indicated to treat certain types of sever seizures has also been launched and the drug saw U.S. sales of approximately $36.3 million for the 12 months ended Oct. 31, 2016.
Mylan said it currently has 240 abbreviated new drug applications pending before the FDA, which it says represent some $95.6 billion in brand sales, with 41 of the ANDA’s potential first-to-file opportunities.
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