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    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
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    FDA Warns Teva’s Banned Hungary Manufacturing Facility

    The US Food and Drug Administration (FDA) has warned Teva’s Gödöllő, Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program. The warning letter, sent on 14 October, followed FDA’s eight-day current Good Manufacturing Practices (cGMP) inspection of the facility, in January 2016. Teva said in an SEC filing that it “has undertaken corrective actions to address both the ...
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    MHRA Lifts Suspension on Teva Thyroid Drug

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced it has lifted its suspension of Israeli drugmaker Teva Pharmaceuticals' levothyroxine tablets used to treat hypothyroidism. Background MHRA first suspended Teva's marketing authorization for levothyroxine tablets in 2012 following an increase in reports from patients and healthcare practitioners. However, by then, MHRA was already looking into potential differences in effectiveness f...
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    Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

    Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market. Background As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced in August that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-n...
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    Teva’s Cephalon Reaches $125m Settlement With 48 States Due to Generic Delays

    Teva Pharmaceutical’s Cephalon and state attorneys general on Thursday announced a $125 million, 48-state settlement after an investigation into the company’s delaying of generic versions of its top product. Cephalon, which denies any wrongdoing and was acquired by Teva in 2011, was accused of delaying generic versions of its sleep disorder drug Provigil (modafinil). The settlement with every state and Washington, DC (but not including California and Louisiana) follows...
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    Teva to Divest 79 Generic Drugs to Settle FTC Concerns With Allergan Generics Acquisition

    The Federal Trade Commission (FTC) on Wednesday announced that generic drugmaker Teva Pharmaceuticals has agreed to sell its rights and assets to 79 pharmaceuticals to settle FTC charges that its proposed $40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anticompetitive. Teva is currently the largest generic drug company in the US, with an overall market share of about 13%, while Allergan is ranked third, accounting for about 9% of generic ...
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    FDA Evaluating Risk of Burns and Scars With Migraine Patch

    Almost five years since the US Food and Drug Administration (FDA) rejected the approval of the Zecuity migraine patch because of burns (and then later approved a revamped version), the agency said Thursday it’s now investigating the battery-powered patch as “a large number of patients have reported they experienced burns or scars on the skin where the patch was worn.” The evaluation comes as the patch, which delivers sumatriptan and should remain in place for no more tha...
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    FDA Bans Imports From Teva’s Hungary Plant Except Two Drugs in Shortage

    The US Food and Drug Administration (FDA) late last week announced an import alert prohibiting drugs made at the  Gödöllő, Hungary-based manufacturing site from entering the US. However, Teva spokeswoman Denise Bradley told Focus that the ban does not include two drugs that are medically necessary and currently in short supply in the US. Those two drugs are the infection treatment Amikacin and the chemotherapy Bleomycin. “The import alert was issued on May 27 and w...
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    EU High Court Upholds Orphan Exclusivity Ruling

    Earlier this month, the EU's top court upheld a major ruling with implications for orphan drug exclusivity by rejecting an appeal by generic drugmaker Teva Pharmaceuticals Europe. In its appeal, Teva contested the ruling of a lower court that found orphan product exclusivity covers all indications a product is approved for. Background In 2001, Novartis won marketing authorization for its orphan product Glivec (imatinib), marketed as Gleevec in the US, as a first-line t...
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    EU Court Rules on Orphan Product Exclusivity

    A European Court has issued a ruling in an unlikely scenario dealing with overlapping periods of orphan product market exclusivity. In its ruling, which has the potential to influence how companies develop orphan products, the court found that authorized orphan products are entitled to market exclusivity, even when they are similar to an already approved product. Background Orphan product designation was first introduced in the EU in 2000 under Regulation (EC) No 141...
  • Untitled Letter to Teva Cites Unsubstantiated Claims and Unfair Aesthetics

    A new untitled letter sent by the US Food and Drug Administration (FDA) to Teva Neuroscience has found that an article detailer intended to help the company promote its Clozapine tablets is misleading, explaining that it makes unsubstantiated superiority claims while simultaneously omitting facts and minimizing associated risks. Background Clozapine in an antipsychotic approved for the treatment of the symptoms of schizophrenia, but comes with some fairly extensive warn...
  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...