§Why CasetextPricing

Concordia Pharmaceuticals Inc., S.A.R.L. v. Winder Laboratories, Llc et al

REPLY BRIEF re MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

23 Cited authorities

  1. Gilmour v. Gates, McDonald and Co.

    382 F.3d 1312 (11th Cir. 2004)   Cited 1,255 times   2 Legal Analyses
    Holding claim raised in brief in opposition to summary judgment was not before the court on appeal because it was not in the complaint

  2. Weinberger v. Hynson, Westcott Dunning

    412 U.S. 609 (1973)   Cited 364 times
    Holding that the FDA has primary jurisdiction to determine that a product is a ‘new drug,’ subject to review in the court of appeals

  3. Quality Foods v. Latin Am. Agribusiness Devel

    711 F.2d 989 (11th Cir. 1983)   Cited 857 times   1 Legal Analyses
    Holding that liberalized consideration of complaint espoused in Conley "is particularly true in an antitrust suit where the proof and details of the alleged conspiracy are largely in the hands of the alleged co-conspirators."

  4. USV Pharmaceutical Corp. v. Weinberger

    412 U.S. 655 (1973)   Cited 25 times   1 Legal Analyses

    CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT No. 72-666. Argued April 17, 1973 Decided June 18, 1973 Petitioner sells drug products containing citrus bioflavonoid, an extract from fruit skins, as a principal active ingredient. In the 1950's new drug applications (NDA's) were filed and became effective for seven products, and two were sold without any NDA. After the enactment of the 1962 amendments to the Federal Food, Drug, and Cosmetic Act, these products, together with

  5. U.S. v. 225 CARTONS, MORE OR LESS OF ARTICLE

    871 F.2d 409 (3d Cir. 1989)   Cited 57 times
    Affirming the district court's grant of summary judgment

  6. U.S. v. Articles of Drug: 5,906 Boxes

    745 F.2d 105 (1st Cir. 1984)   Cited 27 times
    Providing that "as an exemption to a comprehensive regulatory statute concerned with public safety [i.e., the FDCA], the grandfather clause is to be strictly construed"

  7. U.S. v. Sage Pharmaceuticals

    210 F.3d 475 (5th Cir. 2000)   Cited 5 times   1 Legal Analyses
    Stating that, "[i]n 1962, the [Federal Food, Drug, and Cosmetic Act] was amended to require NDAs to show that a drug is not only safe, but also effective for its intended uses"

  8. United States v. 50 Boxes More or Less

    909 F.2d 24 (1st Cir. 1990)   Cited 4 times

    No. 89-2166. Heard May 9, 1990. Decided July 19, 1990. Daniel R. Dwyer, with whom Peter O. Safir, Kleinfeld, Kaplan and Becker, Mary Morrissey Sullivan, Sullivan, Sullivan Pinta, and Anne S. Davidson, Sandoz Pharmaceuticals Corp., were on brief for defendant, appellants. Mary K. Pendergast, Associate Chief Counsel for Enforcement, Food and Drug Administration, with whom Wayne A. Budd, U.S. Atty., Paul G. Levenson, Asst. U.S. Atty., and Margaret Jane Porter, Chief Counsel, Food and Drug Administration

  9. United States v. An Article of Drug "Bentex Ulcerine"

    469 F.2d 875 (5th Cir. 1972)   Cited 16 times
    Providing that the "Grandfather Clause" exemption to the FDCA's requirement of premarket approval of a "new drug" "is to be strictly construed against the one who invokes its protection"

  10. Upjohn Company v. Finch

    303 F. Supp. 241 (W.D. Mich. 1969)   Cited 18 times
    Taking judicial notice that many corporations incorporate in Delaware but have no other relationship to that state

  11. Rule 9 - Pleading Special Matters

    Fed. R. Civ. P. 9   Cited 38,911 times   316 Legal Analyses
    Permitting "[m]alice, intent, knowledge, and other conditions of a person's mind [to] be alleged generally"

  12. Section 355 - New drugs

    21 U.S.C. § 355   Cited 2,244 times   337 Legal Analyses
    Granting the court discretion to change the date on which an ANDA may be approved if "either party to the action failed to reasonably cooperate in expediting the action"

  13. Section 321 - Definitions; generally

    21 U.S.C. § 321   Cited 1,166 times   161 Legal Analyses
    Defining “new drug”

  14. Section 351 - Adulterated drugs and devices

    21 U.S.C. § 351   Cited 340 times   32 Legal Analyses
    Referencing the U.S. Pharmacopeia's strength, quality, and purity standards

  15. Section 356a - Manufacturing changes

    21 U.S.C. § 356a   Cited 19 times   1 Legal Analyses
    Containing no such requirement

  16. Section 26-4-81 - Substitution of generic drugs or interchangeable biological products for brand name drugs and prescribed biological products

    Ga. Code § 26-4-81   Cited 1 times

    (a) In accordance with this Code section, a pharmacist may substitute: (1) A drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or (2) A biological product with an interchangeable biological product. (b) If a practitioner of the healing arts prescribes: (1) A drug by its generic name, the pharmacist shall dispense the lowest retail

  17. Section 310.502 - Certain drugs accorded new drug status through rulemaking procedures

    21 C.F.R. § 310.502   Cited 14 times

    (a) The drugs listed in this paragraph (a) have been determined by rulemaking procedures to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act and part 314 of this chapter is required for marketing the following drugs: (1) Aerosol drug products for human use containing 1,1,1-trichloroethane. (2) Aerosol drug products containing zirconium. (3) Amphetamines (amphetamine

  18. Section 314.200 - Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing

    21 C.F.R. § 314.200   Cited 10 times   2 Legal Analyses

    (a)Notice of opportunity for hearing. The Director of the Center for Drug Evaluation and Research, Food and Drug Administration, will give the applicant, and all other persons who manufacture or distribute identical, related, or similar drug products as defined in § 310.6 of this chapter, notice and an opportunity for a hearing on the Center's proposal to refuse to approve an application or to withdraw the approval of an application or abbreviated application under section 505(e) of the act. The

  19. Section 310.6 - Applicability of "new drug" or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products

    21 C.F.R. § 310.6   Cited 9 times   2 Legal Analyses

    (a) The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the FEDERAL REGISTER as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced into the market through the new drug procedures from 1938-62 and were submitted for review by the National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study

  20. Section 300.50 - Fixed-combination prescription drugs for humans

    21 C.F.R. § 300.50   Cited 7 times

    The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows: (a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant

  21. Section 310.100 - New drug status opinions; statement of policy

    21 C.F.R. § 310.100   Cited 4 times

    (a) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This

  22. Section 310.545 - Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses

    21 C.F.R. § 310.545   Cited 2 times   3 Legal Analyses

    (a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: (1)Topical acne drug products. Alcloxa Alkyl isoquinolinium bromide Aluminum chlorohydrex Aluminum hydroxide Benzocaine Benzoic acid Boric acid Calcium polysulfide Calcium thiosulfate Camphor Chloroxylenol

  23. Section 310.519 - Drug products marketed as over-the-counter (OTC) daytime sedatives

    21 C.F.R. § 310.519

    (a) Antihistamines, bromides, and scopolamine compounds, either singly or in combinations, have been marketed as ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims have been made for daytime sedative products: "occasional simple nervous tension," "nervous irritability," "nervous tension headache," "simple nervousness due to common every day overwork and fatigue," "a relaxed feeling," "calming down and relaxing," "gently soothe away the tension,"