Related by context. Frequent words. (Click for all words.) 62 Complete Response 61 Complete Response letter 60 Drug Application 59 Paragraph IV 59 Certiorari 59 Marketing Authorization 58 Complete Response Letter 58 Approvable Letter 57 Preliminary Injunction 57 Warning Letter 56 Paragraph IV certification 55 GPhA 55 Proposed Settlement 55 NASDAQ Listing 54 Omnitrope 54 Rehearing 54 Biologics License Application 54 Biologics License Application BLA 54 approvability 53 Position Statement 53 FDA 53 pediatric exclusivity 53 Marketing Authorization Application 53 rehearing en banc 53 Second Amended Complaint 52 BioDelivery Sciences 52 Cholesterol Drug 52 Pirfenidone 52 Summary Judgment 51 supplemental Biologics License Application 51 sBLA 51 approvable letter 51 Dkt 51 Amended Complaint 51 Counterclaim 51 Final Approval 51 Full Prescribing Information 51 Synthon 50 Final Determination 50 Staff Determination Letter 50 Marketing Authorization Application MAA 50 Memorandum Opinion 50 Horizant 50 Onsolis 50 European Medicines Evaluation 50 Shelf Registration Statement 50 NYSE BRL 50 Hormone Therapy 50 Reorganization Plan 50 summary judgment motions 50 sNDA 50 Cervical Cancer Vaccine 50 Teva Pharmaceuticals USA 50 CHMP 50 Phase III Clinical Trial 49 Act PDUFA date 49 Doc. # 49 Patent Litigation 49 Petition 49 Doc. No. 49 ANDAs 49 Sparlon 49 NYSE MYL 49 Prescribing Information 49 Intellipharmaceutics 49 Tygacil 49 Gestiva 49 Rosiglitazone 49 NOXAFIL 49 Mutual Recognition Procedure 49 Avastin bevacizumab 49 anti SLAPP motion 49 ANDA 49 Upsher Smith 48 Doc. 48 orphan designation 48 Oscient Pharmaceuticals 48 PDUFA date 48 Drugs Advisory 48 Cladribine 48 DCGI 48 GRAS status 48 Hatch Waxman Act 48 Drug Candidate 48 Fast Track Designation 48 END FOOTNOTE 48 Oral Solution 48 Ampligen 48 Javelin Pharmaceuticals 47 FIRAZYR 47 Initial Determination 47 Paladin Labs Inc. 47 Investigational Device Exemption 47 USFDA 47 Nasal Spray 47 Patent Suit 47 Low Dose 47 Medicis Pharmaceutical Corporation 47 bazedoxifene 47 Risperidone 47 Lamivudine