calendar
7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
7,990 catalysts · 3,350 8k filing · 1,368 grant · 1,000 device adverse event · 615 approval · 582 earnings · 476 device 510k
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700. — Reason: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. — Status: Ongoing
AA grant. $249,000. PI: Bryan Cruz
MH grant. $990,550. PI: Susan Faja
MH grant. $431,750. PI: Michael Roland Williams
HL grant. $249,000. PI: Tetsushi Nakao
GM grant. $421,737. PI: Sarah Kostinski
MH grant. $800,384. PI: Vikaas Singh Sohal
EB grant. $174,861. PI: Theodora E Wingert
HL grant. $445,000. PI: Sahand Hormoz
HL grant. $53,507. PI: Nathalie Chen
MH grant. $1,611,088. PI: Zhuhao Wu
NS grant. $415,717. PI: Darcie Leann Moore
GM grant. $487,287. PI: Akhilesh Basi Reddy
GM grant. $94,154. PI: Lisa Jaremka
MH grant. $838,378. PI: Marcelo Dietrich
MH grant. $800,667. PI: Matthias Stadtfeld
AR grant. $20,000. PI: Ann W. Silk
MH grant. $49,416. PI: Brenna Duffy
GM grant. $737,152. PI: Kenichi Yokoyama
GM grant. $375,898. PI: Darryl A Wesener
DK grant. $616,107. PI: Sae Takada
GM grant. $1,600,449. PI: Ethan Clark Garner
HL grant. $1,069,072. PI: Yan-Qing Ma
DK grant. $847,068. PI: JENIFER ELIZABETH ALLSWORTH
EB grant. $722,392. PI: Xiaoyue Ni
CA grant. $4,000. PI: Rushika Miriam Perera
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: ENCUBE. Form: GEL, METERED. Route: TRANSDERMAL
Sponsor: STRIDES PHARMA INTL. Form: CAPSULE. Route: ORAL
Sponsor: ZYDUS LIFESCIENCES. Form: CAPSULE. Route: ORAL
Sponsor: BIOCON PHARMA. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL
Sponsor: LABORATORIOS GRIFOLS. Form: INJECTABLE. Route: INJECTION
Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: ALEMBIC. Form: CAPSULE, DELAYED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL
Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL
Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: SAVIOR LIFETEC CORP. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: AYRMID PHARMA. Form: POWDER. Route: SUBCUTANEOUS
Sponsor: GLAND. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 — Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. — Status: Ongoing
Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01. — Reason: CGMP Deviations — Status: Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04. — Reason: CGMP Deviations — Status: Ongoing
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. — Reason: Defective container; inadequately sealed blister packaging. — Status: Ongoing
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. — Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution — Status: Ongoing