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- INAMED Receives FDA Approvable Letter for Its Responsive Silicone Gel Filled Breast Implants
- SANTA BARBARA, Calif. -- INAMED Corporation (Nasdaq:IMDC), a global healthcare company, today announced that it has received an "approvable letter" from the Food and Drug Administration FDA for its responsive silicone gel filled breast implants. The approvable letter stipulates a number of conditions that INAMED must comply with in order...
- Research articles 2005-09-21
- Barrier Therapeutics Announces FDA Acceptance of Its New Drug Application for Sebazole(TM) Topical Gel
- Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company developing and commercializing products in the field of dermatology, today announced that the U.S. Food and Drug Administration FDA has accepted for filing the Company's New Drug Application NDA for SebazoleTM (ketoconazole USP 2%) topical gel for the treatment of seborrheic dermatitis....
- Research articles 2005-12-09
- SOLVAY Pharmaceuticals.(receives approval for AndroGel 1 percent)(Brief Article)
- SOLVAY Pharmaceuticals' Unimed has received FDA approval for its AndroGel 1 percent (testosterone gel, C-III). The approval marks the first-ever testosterone replacement gel to be approved by FDA for replacement therapy in men for ... SOLVAY Pharmaceuticals' Unimed has received FDA approval for ...
- Research articles 2000-03-06
- Columbia Laboratories Submits U.S. New Drug Application for Crinone, Its Locally-Delivered Natural Progesterone Gel
- MIAMI--HealthWire--July 24, 1996--Columbia Laboratories, Inc. (ASE: COB) today announced the submission of a New Drug Application NDA to the U.S. Food and Drug Administration FDA for clearance to market CrinoneR, its locally-delivered natural progesterone gel, as a hormonal therapy for patients with secondary amenorrhea loss of menstrual period....
- Research articles 1996-07-24
Additional Resources
- Mentor Receives Approvable Notification From FDA for Its Silicone Gel-Filled Breast Implants
- SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has received an "approvable letter" from the U.S. Food and Drug Administration FDA for the Company's MemoryGelTM silicone gel-filled breast implants. The approvable letter stipulates a number...
- Research articles 2005-07-28
- Inamed Submits PMA for Its Next Generation Silicone Gel-Filled Breast Implants — and — Announces Pending Silicone Gel-Filled Breast Implants PMA Will Be Reviewed at an Upcoming FDA Panel Meeting
- SANTA BARBARA, Calif. -- --Bio-DimensionalTM Cohesive Gel Matrix Style 410 PMA Submitted To FDA
- Research articles 2004-12-06
- Statement by Sybil Niden Goldrich, Command Trust Network on FDA Panel Tentatively Set for Silicone Gel Breast Implants in April 2005
- LOS ANGELES -- Goldrich is responding to announcements today by the Mentor and Inamed Corporations that the FDA has tentatively set a panel date to review silicone gel breast implants. Inamed also announced that it had submitted its documentation for approval of a new type of cohesive gel silicone breast...
- Research articles 2004-12-06
- Allergan Announces FDA Approval of Juvederm® Gel Family of Products for the Treatment of Facial Wrinkles and Folds; 'Next Generation' Smooth Gel, Non-Animal Dermal Fillers Offer Natural, Long-Lasting Results
- IRVINE, Calif. -- Allergan, Inc. (NYSE:AGN), the makers of BOTOXR Cosmetic Botulinum Toxin Type A, today announced the U.S. Food and Drug Administration FDA's approval of the JuvedermR gel family of products, a 'next generation' of hyaluronic acid dermal fillers that provide a smooth, long-lasting correction of facial wrinkles and...
- Research articles 2006-06-05
- BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel®
- LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (Amex:BPA) announced today that its new drug application NDA for Bio-E-Gel transdermal estradiol gel, an innovative low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the U.S. Food and Drug Administration FDA.
- Research articles 2006-04-19
- INAMED Files Amendment with FDA for BioDimensional™ Style 410 Matrix Cohesive Gel Implant PMA
- SANTA BARBARA, Calif. -- INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today announced that it has submitted an amendment to its cohesive gel breast implant (BioDimensionalTM Style 410 Matrix) premarket approval application PMA currently under review by the Food and Drug Administration FDA. The Style 410 PMA was submitted to...
- Research articles 2005-11-18
- Akorn, Inc. Receives NDA Approvable Letter for Akten® Ophthalmic Gel 3.5%
- BUFFALO GROVE, Ill. -- Akorn, Inc. (NASDAQ: AKRX) today announced the receipt of an FDA approvable letter for Akten[R] Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. Our approvable letter identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted. The majority of...
- Research articles 2008-06-04
- Questcor Files sNDA for Treatment of Infantile Spasms with H.P. Acthar® Gel; FDA Accepts Application for Review
- UNION CITY, Calif. -- Questcor Pharmaceuticals, Inc. (AMEX:QSC) announced today that the U.S. Food and Drug Administration FDA has accepted for review its supplemental new drug application sNDA seeking approval for H.P. ActharR Gel repository corticotropin injection for the treatment of infantile spasms. Questcor anticipates that the FDA will take...
- Research articles 2006-08-23
- INAMED Submits Supplemental Data for Its Pending Silicone Gel-Filled Breast Implant PMA to the FDA
- SANTA BARBARA, Calif. -- INAMED Corporation (Nasdaq:IMDC), a global health care company, announced today that it has submitted its formal response to the January, 2004 not approvable letter it received from the FDA concerning the Premarket Approval Application PMA for its silicone gel-filled breast implants. In this supplemental submission, additional...
- Research articles 2004-08-19
- FDA Schedules Advisory Panel Hearing for Mentor's Silicone Gel-Filled Breast Implant PMA
- SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has been notified by the U.S. Food and Drug Administration FDA that the Company's silicone gel-filled breast implant PreMarket Approval PMA application will be reviewed by an...
- Research articles 2004-12-06
- FDA Advisory Panel Recommends Conditional Approval of Mentor Silicone Gel-Filled Breast Implants; Patient Advocates Hail Decision as Victory for Women Considering Breast Augmentation or Reconstruction
- SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that an advisory panel to the U.S. Food and Drug Administration FDA determined that the Company's silicone gel-filled breast implants are safe and effective for use in breast reconstruction...
- Research articles 2005-04-13
- Mentor Submits Silicone Gel Breast Implant PMA Amendment to the FDA
- SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it had submitted to the U.S. Food and Drug Administration FDA an amendment to the Company's silicone gel breast implant Pre-Market Approval PMA application. The amendment is focused...
- Research articles 2004-08-31
- Inamed Receives FDA Letter Requesting Additional Information for Its Style 410 Cohesive Gel Breast Implant PMA Application
- SANTA BARBARA, Calif. -- Inamed Corporation (NASDAQ:IMDC), a global healthcare company, announced that it has received a letter from the U.S. Food and Drug Administration FDA with respect to its Style 410 cohesive gel-filled breast implants premarket approval PMA application.
- Research articles 2005-04-04
- FDA Clears REGRANEX — becaplermin — Gel 0.01% for Diabetic Foot Ulcers; Chiron to Supply Active Ingredient to Ortho-McNeil
- EMERYVILLE, Calif.--BW HealthWire--Dec. 17, 1997--Chiron Corporation (NASDAQ:CHIR) today announced that the U.S. Food and Drug Administration FDA has granted Ortho-McNeil Pharmaceutical Inc., marketing clearance for REGRANEXR becaplermin Gel 0.01%, the first biologic proven to increase the incidence of complete healing in diabetic foot ulcers.
- Research articles 1997-12-17
- Ligand Pharmaceuticals' Panretin Gel for Aids-Related KS to Receive FDA Priority Review
- SAN DIEGO--BW HealthWire--July 13, 1998--Ligand (LYE-gand) Pharmaceuticals Incorporated (NASDAQ:LGND) has announced that the company's New Drug Application NDA for PanretinR gel alitretinoin 0.1% for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma KS has been accepted for priority review by the U.S. Food uires the FDA...
- Research articles 1998-07-13
- Inamed's Pending Silicone Gel-Filled Breast Implants PMA Supplemental Submission Scheduled for FDA Panel Meeting
- SANTA BARBARA, Calif. -- Supplemental Submission for Pending Silicone Gel-Filled Breast Implants PMA to Be Reviewed at the FDA's General and Plastic Surgery Devices Advisory Panel on April 11-13, 2005
- Research articles 2005-01-18
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