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Generics

  • Perrigo gets FDA approval for generic Mycolog II cream

    SILVER SPRING, Md. — Perrigo has received Food and Drug Administration approval for its generic of Mycolog II cream (nystatin and triamcinolone acetonide cream, 100,000 units/g and 1 mg/g) cream, the company announced Wednesday.

  • Lupin, Natco Pharma get FDA approval for Fosrenol chewable generic

     

    SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s and its alliance partner Natco Pharma’s generic of Fosrenol (lanthanum carbonate) chewable tablets, the companies announced Monday. The two companies joined together in 2008 to jointly commercialize this product, which is the first generic of Fosrenol chewable tablets.

  • FDA looks to foster generics competition

    In an effort to bring down the price of prescription drugs, the Food and Drug Administration’s new commissioner, Dr. Scott Gottlieb, has made increasing competition among generics manufacturers one of his top priorities. Gottlieb unveiled the Drug Competition action plan in late June. Ahead of a July 18 public meeting, the agency released a list of branded drugs that currently have no listed patents or exclusivities, and also have no generics.

  • Mylan launches 3 HIV generics in Canada

    HERTFORDSHIRE, England, PITTSBURGH and TORONTO — Mylan has launched three generics for treating HIV in Canada. Among the three launches is the company’s generic of Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate, 200 mg/300 mg), as well as generics of Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate, 600 mg/200 mg/300 mg) and Viread (tenofovir disoproxil, 300 mg).

  • FDA approves Lupin’s Nikita
    SILVER SPRING, Md. — The Food and Drug Administration has granted Lupin approval for its Nikita (pitavastatin sodium) tablets, the company announced Wednesday. The drug is indicated as an adjunctive therapy to diet to reduce high total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides while raising HDL cholesterol.
     
    Lupin said it is an alternate salt product of Kowa’s Livalo (pitavastatin calcium). There is no generic of Livalo that has been approved by the FDA. 
     

  • Perrigo gets tentative FDA approval for Mirvaso gel generic

    SILVER SPRING, Md. — The Food and Drug Administration has granted Perrigo tentative approval for its generic of Mirvaso Gel (brimonidine topical gel, 0.33). Perrigo said it had previously settled litigation with Galderma Laboratories and Nestle Skin Health for the product.

    The drug is indicated to treat persistent (nontransient) erythema of rosacea in adults ages 18 years and older. It had a U.S. market size of $31 million for the 12 months ended June 2016.

  • FDA Reauthorization Act heads to Trump’s desk after Senate passage

    WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

  • Teva intros generic Relpax

    NORTH WALES, Pa. — Teva on Wednesday announced the launch of its generic of Relpax (eletriptan HBr) tablets. The drug is indicated to treat migraine headaches.

    “Our customers count on Teva for a continuous supply of new generic products,” Teva North American generics COO Maureen Cavanaugh said. “With the launch of eletriptan hydrobromide tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”

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