The US Food and Drug Administration (FDA) has approved Aprecia Pharmaceuticals Company's Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.
The European Commission (EC) has approved under the European Union (EU) Merger Regulation the Pfizer Inc's pending acquisition of Hospira, Inc. The Commission's decision includes Pfizer’s commitment to divest certain assets.
Taro Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Keveyis™ (dichlorphenamide) 50 mg Tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis.[1] Keveyis is the first medicine approved by the FDA for the treatment of primary periodic paralysis, which is estimated to affect approximately 5,000 people in the United States.[2]
Hetero Group, one of India’s leading generic pharmaceutical companies has recently announced the launch of its biosimilar ‘Rituximab’ under the brand name Maball in India. It will be marketed and distributed by Hetero Healthcare Limited, a group company of Hetero. Rituximab is recommended as the first-line treatment for NHL and is available in a single dose vial with two strengths – 100mg/10ml and 500mg/50ml.
Dr Reddy's Laboratories has entered into a strategic collaboration with Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. Under the terms of the collaboration, DRL will launch Kyprolis (carfilzomib), Blincyto (blinatumomab and Repatha (evolocumab) in India.
Ajanta Pharma Limited, a Rs.1,450 crore plus Mumbai based specialty focused pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (FDA) for its 3 Abbreviated New Drug Applications (ANDAs), montelukast tablets, 10mg, montelukast sodium chewable tablets, 4mg & 5mg and montelukast oral granules.
Pharma Major Lupin Limited (Lupin) today announced the opening of its new Center of Excellence for Inhalation Research in Coral Springs, Florida. Local and state leaders, including Florida Lieutenant Governor Carlos Lopez-Cantera, Florida Department of Economic Opportunity Director Jesse Panuccio, and Mayor Skip Campbell, were on site to celebrate the opening of Lupin’s new facility with a ribbon cutting ceremony.
ANI Pharmaceuticals, Inc., an integrated specialty pharmaceutical company, announced that its ANDA collaboration partner Sofgen, received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nimodipine 30mg capsules. ANI and Sofgen expect to begin shipping to customers this year.
MedPlus has recently launched e-commerce service ‘Click. Pick & Save’ in Delhi and NCR area. With this launch, the service is available in all the top metro areas of the country except Mumbai.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Merck's investigational antibiotic Zerbaxa (ceftolozane and tazobactam). This is used for the treatment of the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections in adults.
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