Ironwood Pharmaceuticals Inc. and Allergan plc announced that the companies reached an agreement with Mylan Pharmaceuticals Inc. resolving patent litigations brought in response to Mylan’s abbreviated new drug applications seeking approval to market generic versions of Linzess (linaclotide) before the expiration of the companies’ applicable patents.
Amring Pharmaceuticals Inc. – a generic pharmaceutical company – announced that it acquired six ANDAs from Luitpold Pharmaceuticals Inc. and AlphaForce L.L.P., a joint venture between Luitpold and Alphagen Laboratories Inc.
Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Memantine Hydrochloride Tablets USP, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent […]
MUMBAI, India, Sept. 3, 2015 /PRNewswire/ — Cipla, a global pharmaceutical company which uses technology and innovation to meet the everyday needs of all patients, today announced that its UK arm, Cipla EU has entered into definitive agreements to acquire two US-based companies, InvaGen Pharmaceuticals Inc., and Exelan Pharmaceuticals Inc. The transaction being subject to certain […]
HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced that the U.S. Patent and Trademark Office (PTO) has instituted inter partes review (IPR) proceedings against two Copaxone® 40 mg/mL patents, U.S. Patent Nos. 8,232,250 and 8,399,413, owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries […]
HERTFORDSHIRE, England and PITTSBURGH, Aug. 25, 2015 /PRNewswire/ — Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer’s Zosyn® Injection. This product is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for the treatment of patients with moderate to […]
MAPLE GROVE, Minn., Aug. 10, 2015 /PRNewswire/ — Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of an abbreviated new drug application (ANDA) for Memantine Hydrochloride Tablets in 5 mg and 10 mg strengths. Memantine Hydrochloride Tablets are equivalent to the branded product, Namenda®, which is indicated for […]
DUBLIN, July 30, 2015 /PRNewswire/ — Allergan plc (NYSE: AGN) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Treprostinil Inhalation Solution, 0.6 mg/mL, 2.9 mL ampules. Allergan’s ANDA product is a generic version of United Therapeutics Corporation’s Tyvaso®, which is […]