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…drug, manufacturers must provide the following: Name of prescription drug; Identify whether brand name or generic; Effective date of the change in WAC; Aggregate, company-level research and development costs for…
…how and how not to communicate with FDA’s Office of Generic Drugs (“OGD”). Forum presenters will also address how the legal landscape for generic drug companies has changed over the…
…to a pending ANDA for a generic version of DORYX (doxycycline hyclate) Delayed-Release Tablets, an old antibiotic drug, which ANDA contains a Paragraph IV certification to a patent listed in…
…holder or patent owner may choose to sue a generic applicant for patent infringement if the generic applicant submits an ANDA containing a Paragraph IV certification to an Orange Book-listed…
…(H.R. 6160) – that is intended to direct companies “to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature…
…approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release Tablets, 500 mg. In January 2008, the U.S. District Court for the District of Columbia…
…180-day generic drug and pediatric exclusivity issues involving NORVASC (amlodipine besylate) Tablets and the availability of generic versions of the drug product. Mylan’s amlodipine drug product is the only generic…
CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today…
…letters: Not Acceptable Letter: The submission is found to be administratively incomplete. Approval Letter: FDA approves of the proposed plan as submitted. Minor Deficiency Letter: There are minor deficiencies that…
…at the agency and the Office of Diversion Control. Ms. Carter stated that the agency is considering issuing further clarification of suspicious order requirements, possibly a regulation specifying the format…
…this brief provides the clearest statement of FDA’s limited authority to compel a recall. We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company…
…“shall . . . issue an order withdrawing approval” language at FDC Act § 512(e)(1) comes into play – as follows: The principal question presented by this appeal is whether…
…the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional because the ban violates the Supremacy Clause of the U.S. Constitution (as well as the dormant Commerce…
…Complaint in May 2011 seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final…
…2021, unless DEA receives significant adverse comment. DEA will withdraw the rule by September 20, 2021, if it receives significant adverse comment. Electronic comments must be submitted, and written comments…