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…Certifications List, the first ANDA for a generic version of Eli Lilly and Company’s (“Lilly’s”) CIALIS (tadalafil) Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg, containing a Paragraph…
…failed to exhaust administrative remedies. According to FDA: In an attempt to avoid these major flaws in its case, Teva argues that an FDA decision regarding another generic drug that…
…in the MGP/Wockhardt brief recently filed with the Court of Common Pleas of Philadelphia County in In re: Reglan/Metoclopramide Litigation. According to MGP/Wockhardt: Plaintiffs here are improperly, and without the…
…original)] Moreover, says Actelion, there are alternatives to the ANDA approval route that companies can use: For example, the potential generic competitors here can develop drug products with the exact…
…received a Complete Response Letter for this ANDA on March 13, 2013, which included the same bloequivalence deficiencies communicated in the Agency’s March 13, 2012 Bioequivalence Comments. Zydus promptly responded…
…equivalent products). According to the Conference Report: The conferees request the FDA report on adverse events and seizures associated with brand and generic anti-epileptic drugs. Specifically, the agency should examine…
…the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found…
…would more than halve the current median approval time: FDA will hire additional staff to support the review of [ANDAs] for generic drugs and inspections of generic drug manufacturing facilities. …
…a previous post, FDA’s first (of fourteen) legislative proposal targets 180-day generic drug exclusivity, stating: Amend the 180-Day Exclusivity Provisions to Encourage Timely Marketing of First Generics In practice, 180-day…
…clues as to the standard for a “true section viii carve-out.” To Teva, the question presented is simple: “If a generic drug’s FDA-approved label carves out all of the language…
…online ads. Under the consent orders, the companies may not make such representation unless they have evidence to support the claim. They must have competent and reliable evidence to substantiate…
…also reflected in FDA’s online database: Recognized Consensus Standards. The Draft Guidance explains that there are two “primary situations” where FDA may decide to withdraw recognition of a standard: (1)…
…and himself, Mr. Sasinowski offered four recommendations: Proposal #1: FDA should consider the appropriateness of the Accelerated Approval process for every new therapy. Proposal #2: FDA and sponsors should use intermediate clinical…
…that this product is either not included on most third party payor formularies due to the availability of generic equivalents, or, where it is covered, it is placed on non-preferred…
…pathway to transition adult smokers off combustible cigarettes, in light of the increased use by minors, the Agency is now seriously reconsidering the extension of compliance dates for the submission…