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Generics

  • Greenstone intros authorized Relpax generic

    PEAPACK, N.J. — Pfizer subsidiary Greenstone  recently announced the introduction of its authorized generic of Relpax (eletriptan hydrobromide) tablets. The drug is indicated to treat migraine headaches.

    Greenstone’s authorized generic will be available in 20- and 40-mg dosage strengths in blister packs of six tablets per card.

  • FDA gives OK to Lupin’s Lidex generic

    SILVER SPRING, Md. — The Food and Drug Administration has approved Lupin’s generic of Lidex (fluocinonide topical solution, 0.05%), the company recently announced.

    The drug is indicated to relieve inflammatory and pruritic manifestations of dermatoses that are responsive to corticosteroid treatment. The drug had U.S. sales of $32.4 million for the 12 months ended March 2017, according to QuintilesIMS data.

  • Teva intros generic Epiduo in the U.S.

    JERUSALEM — Teva today announced the launch of its generic Epiduo (adapalene and benzoyl peroxide) gel, 0.1%-2.5%, in the United States. The topical treatment is for patients nine years and older with acne vulgaris.

    “I am very pleased that Teva is introducing another first generic product, bringing value to our patients and savings to the U.S. healthcare system,” said Andy Boyer, president and CEO, Global Generic Medicines, North America.

  • FDA approves Acella’s generic Vituz oral solution

    ATLANTA — Acella Pharmaceuticals has received approval from the U.S. Food and Drug Administration for its generic hydrocodone bitartrate and chlorpheniramine maleate oral solution, 5 mg/4 mg per 5 mL, as a bioequivalent of Vituz Oral Solution. The combination medicine is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years and older.

  • Teva’s generic Vagifem launches

    JERUSALEM — Teva on Monday announced the launch of its generic Vagifem (estradiol vaginal inserts). The drug is indicated to treat atrophic vaginitis due to menopause.

  • Merck launches Remicade biosimilar Renflexis

    KENILWORTH, N.J. — Merck on Monday announced the introduction of its Renflexis (infliximab-abda), a biosimilar of Remicade. The Food and Drug Administration approved the drug in April for all eligible indications, and it reflects the first launch under Merck’s global biosimilar partnership with Samsung Bioepis.

  • FDA chief promises ANDA submission guidance by year’s end

    SILVER SPRING, Md. — The Food and Drug Administration’s efforts to improve competition in the generics market — its Drug Competition Action Plan — is officially underway. The regulator held an open meeting on July 18, at which FDA commissioner Scott Gottlieb said would be the beginnings of a new internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.

  • Merck’s follow-on biologic Lusdana Nexvue gets tentative FDA approval

    SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to Merck’s follow-on biologic basal insulin Lusdana Nexvue (insulin glargine injection), the company announced Thursday. The tentative approval notes that the drug has met the required regulatory standards, but is subject to an automatic stay, as Sanofi has claimed patent infringement on its insulin product Lantus.

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