The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon. The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present […]
NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system. The drug, Glatiramer Acetate, will be manufactured by NATCO and sold by Mylan, and are […]
Pharmaceuticals and specialty chemicals maker Vivimed Labs said investment firm OrbiMed will invest $42.5 mn (Rs 270 cr) into its active pharmaceutical ingredients business. The investment will be into Vivimed Labs Mascarene Ltd, which is in turn the holding entity of the company’s API business, UQUlFA. The proceeds of this fund raise will be utilised […]
Glenmark Pharmaceuticals Inc said it has got the go-ahead to launch the generic version of Perrigo’s anti-inflammation ointment Desonide Ointment in the US. Desonide Ointment, 0.05% had annual sales of approximately $23.4 million for the 12 month period ending July 2017, according to IMS Health sales data. Glenmark’s current portfolio consists of 124 products authorized […]
Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident. “US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility in Wishakhapatnam, Andhra Pradesh from September 11 to 15, 2017 and completed the audit without any observations,” it said. No form 483 was issued, it […]
Zydus Cadila said it received the final regulatory approval to market anti-sleep drug Modafinil in the US, and tentative approval for bladder control drug Solifenacin Succinate. Unlike a final approval, tentative approvals don’t allow the grantee to sell the drugs in the US market immediately. They have to wait for the patents to expire. The […]
Pharma company Panacea Biotec said it has signed an agreement to supply a generic version of Eli Lilly’s Effient heart drug to Apotex, the largest Canadian-owned pharmaceutical company. The drug will be sold by Apotex in the US market. “Under the terms of the agreement, Apotex shall be responsible for sales & distribution of the […]
Pharma company Jubilant Life Sciences Ltd said it received final approval to sell pain drug Indomethacin in the US. The drug, which is also sold as Indocin by Iroko in the US, is a nonsteroidal anti-inflammatory drug used for the treatment of moderate to severe inflammation and reduce pain. “This is the seventh approval that […]
Glenmark Pharmaceuticals said it has got the US FDA approval to sell the generic version of corticosteroid ointment Kenalog from Mylan Pharmaceuticals. The primary ingredient is triamcinolone, a corticosteroid that reduces the actions of chemicals in the body that cause inflammation. Kenalog Ointment has annual sales of approximately $26.3 million in the US. Glenmark said […]
Pharmaceuticals company Lupin said it received a 505 (b)(2) NDA approval for its Nikita”M (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA). A 505(b)(2) approval refers to one given by relying on studies already performed on a previously approved drug. The product is an alternate […]
Pharma company Strides Shasun said it had received approval allergy drug Cetirizine Hydrochloride in the US. “The US market for Cetirizine Hydrochloride Capsules (Softgel) is approximately USD 60 mln, with only one other generic player,” the company said. “The product is ready for launch immediately and as in the case of OTC products, the market […]
Glenmark Pharmaceuticals said it received approval from UK authorities for to sell its Maloff Protect anti-malarial medication without prescription. It contains atovaquone and proguanil hydrochloride, and has been available only as a prescription medicine in the UK. The Medicines and Healthcare products Regulatory Agency gave approval for 250mg and 100mg film-coated tablets, it said. Maloff […]
Sun Pharma said it has inked a long-term agreement with Samsung BioLogics under which the Korean company will manufacture Tildrakizumab, a potential treatment for plaque psoriasis, for the Indian company. Plaque psoriasis is an autoimmune condition which results in patches of thick, red, scaly skin. The approximate value of the contract will be US$ 55.5 […]
Pharmaceutical company Strides Shasun said it received approval from the United States Food & Drug Administration to sell nausea drug Promethazine Hydrochloride in the country. The US market for Promethazine Hydrochloride tablets is approximately USD 17 Million. It will be sold in three doses ranging from 12.5 mg to 50 mg. Promethazine Hydrochloride Tablet is […]
Unichem Laboratories said the US FDA has completed its inspection of the company’s formulations manufacturing facility in Goa. The facility has received an Establishment Inspection Report, the company added. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). The inspection has now been closed by the […]
Zydus Cadila said it received the final approval from the US FDA to market obesity drug Phentermine Hydrochloride. The drug will be marketed in the form of orally disintegrating tablets in strengths of 15 mg, 30 mg, and 37.5 mg. The drug is used to treat obesity in people with risk factors such as high […]
Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals received final approval from the US Food and Drug Administration to sell generic drug Dextroamphetamine Sulfate. Dextroamphetamine is a central nervous system stimulant used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and in the treatment of narcolepsy (a Special type of sleep disorder), Zydus Cadila said. […]
Zydus Cadila has received the final approval from the the US Food and Drug Administration to market Hepatitis B drug Entecavir. The drug has sales of $166.3 million in the US, and will be sold in 0.5 mg and 1 mg dosage. It will be produced at the group’s formulations manufacturing facility at the Pharma […]
Glenmark Pharmaceuticals said it received final approval from the United States Food & Drug Administration for marketing a generic version of joint-pain drug Indocin of Iroko Pharmaceuticals. The drug has annual sales of approximately $6.3 million. With this, Glenmark’s portfolio has expanded to 118 products authorized for distribution in the U.S. and 67 pending approvals […]
Pharma Major Lupin said it launched Desoximetasone cream for treating skin problems in the US market. The company had received approvals from the US Food and Drug Administration earlier. The drug is the generic equivalent of Tarot Pharma’s Topicort, which had US sales of $38 million per year. The drug is used for relief of […]
