FDA approves Mylan’s generic Dilantin chewable tablets
PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.
The product is a generic version of Pfizer’s Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin chewable tablets USP 50 mg, had U.S. sales of approximately $16.5 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan is shipping this new product immediately.
Currently, Mylan has 185 Abbreviated New Drug Applications pending FDA approval, representing $80.6 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
Mylan generic heart drug suit against FDA dismissed
WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.
U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.
“Given Mylan’s status as a leading generic manufacturer and its already large market presence, the potential financial impact on Mylan’s business is too small to support a finding of irreparable harm,” Bates wrote in the 25-page opinion.
Mylan had argued in the lawsuit that Ranbaxy Laboratories, a competitor, had forfeited its right to six-month exclusivity to sell the generic drug by not winning FDA approval. The FDA’s refusal to approve its sale of the drug was arbitrary, capricious and an abuse of discretion, Mylan asserted.
Mylan, based in Canonsburg, Pa., announced a copy of Diovan HCT on Sept. 21. The generic version is a combination of the Novartis drug and hydrochlorothiazide, a diuretic. At the time, Novartis began marketing a branded version of the drug through its generics unit.
Mylan launches new generic oral contraceptive
PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.
The product is a generic version of Teva Branded Pharmaceutical Products’ Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.
Mylan currently has 34 oral contraceptives pending approval with the FDA and expects to receive additional approvals within next year’s first quarter, said Heather Bresch, Mylan CEO.
Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg, had U.S. sales of approximately $60.4 million for the 12 months ended Sept. 30, 2012, according to IMS Health.