Industry News

- Read more about Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Oral Solution, 10 mg/mL
Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat® Oral Solution, 10 mg/mL of UCB, Inc. Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Orange Book for Vimpat® Oral Solution, 10 mg/mL is scheduled to expire on March 17, 2022.
- Read more about Aurobindo Pharma receives USFDA approval for Naproxen Sodium Tablets (OTC)
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC). This product is expected to be launched in Q1 FY16-17.
- Read more about Albumedix drug delivery technology used by CSL behring to achieve 14 day dosing for Haemophilia B therapy
Albumedix announced that its albumin-based VELTIS® half-life extension technology is being used by CSL Behring in IDELVION®, a therapy recently authorized for the treatment of haemophilia B in the U.S. The application of Albumedix’s VELTIS technology in the drug delivers an extended half-life which will improve the lives of patients living with the condition by reducing the frequency of injections up to once every 14 days. The U.S. Centers for Disease Control and Prevention, report that the condition affects approximately one in 25,000 male births.
- Read more about Anacor Pharma announces FDA acceptance of NDA for Crisaborole Topical Ointment, 2%
Anacor Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Anacor's New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
- Read more about Aratana therapeutics granted first FDA approval of GALLIPRANT
Aratana Therapeutics, Inc., a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, announced the Food and Drug Administration's Center for Veterinary Medicine (CVM) approved GALLIPRANT® (grapiprant tablets) for the control of pain and inflammation associated with osteoarthritis in dogs.
- Read more about EOS imaging receives CFDA approval for the EOS® system
EOS imaging announced that the Company has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China, further expanding the Company’s commercial opportunities in the fast growing Asia Pacific market. The EOS system can now be marketed in 51 countries.

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- Read more about LEO Pharma recieves scientific approval of Enstilar® in EU
LEO Pharma announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.
- Read more about Aurobindo Pharma receives USFDA Approval for Ibandronate Sodium Tablets
Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ibandronate Sodium Tablets, 150 mg. This product is expected to be launched in Q1 FY16-17.
- Read more about Eagle Pharma receives complete response letter from FDA on KANGIO (RTU bivalirudin) application
Eagle Pharmaceuticals, Inc. announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its KANGIO™ (bivalirudin injection), 505(b)(2) New Drug Application for a ready-to-use (“RTU”), stable liquid intravenous formulation of 5 mg/mL bivalirudin in a 50-mL vial intended for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention (“PCI”) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (“HIT”) and thrombosis syndrome (“HITTS”), and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (“PTCA”).
- Read more about FDA 510(k) clearance granted to PneumaCare’s ground-breaking Thora-3DI™
PneumaCare Ltd announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Thora-3DI™ imaging device.Thora-3DI™ is a non-invasive, non-contact device that uses a patented technology known as structured light Plethysmography (SLP) to measure breathing through detection of movement of the chest and abdomen.