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Generics

  • FDA approves Aurobindo’s Loestrin generic line Aurovela

    SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s Aurovela — its line of five generic Loestrin products. The line of oral contraceptives are indicated to prevent pregnancy.

    The products include:

  • AAM adds federal affairs director, promotes Brzica to VP

    WASHINGTON — The Association for Accessible Medicines has announced two changes to its federal affairs team. The organization on Monday named Kristin Murphy its director of federal affairs, promoting Michael Brzica to the role of VP federal government affairs.

  • Perrigo gets FDA OK for generic Androgel packets

    SILVER SPRING, Md. — The Food and Drug Administration has approved Perrigo’s generic of AbbVie’s Androgel Topical Gel 1.62% packets (testosterone 20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet).

    The drug is an androgen indicated for replacement therapy in makes for conditions associated with an absence or deficiency of endogenous testosterone. The drug had annual U.S. sales of $88 million for the 12 months ended May 2017, according to QuintilesIMS data. Perrigo said the approval was for its first-to-file application. 

  • FDA approves Impax’s generic extended-release Concerta
    SILVER SPRING, Md. — The Food and Drug Administration has approved Impax Laboratories’ generic of Concerta (methylphenidate hydrochloride) extended-release tablets. The drug is indicated too treat attention deficit hyperactivity disorder in patients older than 6 years of age.
     

  • Report: Jean Coutu criticizes government negotiations regarding dispensing fees

    Jean Coutu founder Jean Coutu spoke out regarding negotiations with Quebec around dispensing fees, according to a report published last week by Canada's Bell Media. Jean Coutu earlier this year agreed to surrender $300 million in collected dispensing fees in return for smaller manufacturer rebates that cut into pharmacy operating margins. "It is an average of $100,000 for each of our locations," Coutu told shareholders BellMedia reported.

  • PhRMA adds 2 VPs
    WASHINGTON — The Pharmaceutical Research and Manufacturers of America this week announced two new additions to its ranks. The company has added Mike Hotra as VP of its public affairs team, and Ken McKay as VP state government affairs. 
     

  • Teva intros 2 new strengths of ADHD generic

    NORTH WALES, Pa. — Teva recently added two new dosage strengths to its line of generic Focalin XR (dexmethylphenidate HCl) extended-release tablets. The company now offers 25- and 35-mg dosage strengths of the tablets.

    The drug indicated to treat patients ages 6 years and older with attention deficit hyperactivity disorder. Teva’s generic is now available in 5-. 10-, 15-, 20-, 25-, 30-, 35- and 40-mg dosage strengths.

  • AAM adds deputy general counsel

    WASHINGTON — The Association for Accessible Medicines has named a new deputy general counsel. Rachel Sher joins the advocacy organization from her role as a senior policy analyst in the Food and Drug Administration’s Office of Policy.

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