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Hyman, Phelps & McNamara, P.C. Document Search Results (254) Show: results per page Sort by:  | A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2013, previously published on February 11, 2013 A rather interesting and unexpected (to most) ANDA approval popped up on FDA’s website late last week. On February 6, 2013, FDA approved Macleods Pharmaceuticals Limited’s (“Macleods’”) ANDA No. 202467 for a generic version of ACTOS (pioglitazone HCl) Tablets, 15 mg,...
| | FDA Denies Petition to Regulate Prescription Prenatal Vitamins Containing Folic Acid under an Rx Monograph
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 13, 2013, previously published on February 12, 2013 On February 11, FDA issued its response to a December 2009 citizen petition (Docket No. FDA-2009-P-0587-0013) requesting that FDA issue an order confirming that certain prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and mineral, are...
| | Function Over Form or Form Over Function? Two Petitions Challenge FDA’s NCE Exclusivity Approach for Combination Drugs
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 12, 2013, previously published on February 10, 2013 Two recent citizen petitions submitted to FDA - one from Gilead Sciences, Inc. (“Gilead”) under Docket No. FDA-2013-P-0058, and another from Ferring Pharmaceuticals, Inc. (“Ferring”) under Docket No. FDA-2013-P-0119 - take issue with FDA’s long-standing position that...
| | From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2013, previously published on February 4, 2013 Excitement is building (and will soon reach fever pitch) over the U.S. Supreme Court’s March 25, 2012 Oral Argument in Federal Trade Commission v. Watson Pharmaceuticals, Inc. (Docket No. 12-416) concerning whether drug patent settlement agreements (aka “reverse payment...
| | Insanity? A Nearly Unchanged Preserve Access to Affordable Generics Act is Introduced in Congress
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 7, 2013, previously published on February 5, 2013 As if on cue after our post yesterday concerning briefing in FTC v. Watson Pharmaceuticals, Inc. (Docket No. 12-416), where the U.S. Supreme Court will consider whether drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) are...
| | Reissue Patents and FDA’s Hidden Policy on 180-Day Exclusivity: A Vestigial Remnant or More?
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 5, 2013, previously published on February 3, 2013 We don’t like loose ends - especially loose ends in the Hatch-Waxman world! Last June, we posted on FDA’s decisions to require sponsors of ANDAs for generic versions of ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Extended-release Capsules to...
| | New FDC Act Criminal Penalty for Intentional Drug Adulteration Receives Sentencing Commission Consideration
James P. Ellison; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 4, 2013, previously published on January 31, 2013 Earlier this month, the U.S. Sentencing Commission (the “Commission”) issued a Notice of Proposed Amendments to the U.S. Sentencing Guidelines, which are used by federal courts to determine sentences for criminal violations.
| | FDA Advisory Committee Votes 19 to 10 In Favor of Rescheduling Combination Hydrocodone
Delia A. Stubbs; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article February 1, 2013, previously published on January 30, 2013 Last Friday, January 25, 2012, after two days of discussion and deliberation, an FDA Advisory Committee voted 19 to 10 in favor of rescheduling combination hydrocodone from its current placement in Schedule III to Schedule II.
| | FDA Finalizes Guidance on Humanitarian Use Device Designations
Jennifer D. Newberger; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 31, 2013, previously published on January 29, 2013 On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011. The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE). A HUD is a “medical device intended to benefit...
| | HHS Finalizes HIPAA/HITECH Rule: Dramatic Revisions to Marketing Practices and Research Authorizations
Jeffrey N. Wasserstein; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 29, 2013, previously published on January 22, 2013 On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health and Human Services announced the issuance of its much anticipated (and long-awaited) final rule (in prepublication form) relating to the modification to the HIPAA Privacy, Security and Enforcement Rules under the...
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