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6,562 catalysts · 3,603 8k filing · 1,000 device adverse event · 775 grant · 578 earnings · 234 approval · 172 phase 2 completion
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6,562 catalysts · 3,603 8k filing · 1,000 device adverse event · 775 grant · 578 earnings · 234 approval · 172 phase 2 completion
Adverse Event Without Identified Device or Use Problem
Material Rupture
Adverse Event Without Identified Device or Use Problem
Loss of Osseointegration
Failure to Read Input Signal
Failure to Read Input Signal
Adverse Event Without Identified Device or Use Problem
Difficult to Advance; Device Dislodged or Dislocated
Fracture
DE grant. $44,984. PI: Prasun K Datta
DK grant. $34,272. PI: Rebekka Hannah Anderson
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AKEBIA. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44 — Reason: Subpotent Drug — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08. — Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Status: Ongoing
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217. — Reason: Failed tablet specifications. — Status: Ongoing
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Reason: Failed Tablet/Capsule Specifications — Status: Ongoing
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03. — Reason: Lack of Assurance of Sterility — Status: Ongoing
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: HLZ. Advisory committee: Ophthalmic. Type: Traditional
Product code: SHN. Advisory committee: Radiology. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Special