Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US. The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Fesoterodine is used to treat an overactive bladder with Symptoms of urinary […]
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 […]
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 […]
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 giant Zydus Cadila said it received final approval from the USFDA to market immunonsuppressant Mycophenolate Mofetil injection. The drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants. The drug will be manufactured at the group’s […]
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 […]
Zydus Cadila said it has received approval from the US Food and Drug Administration to market chemotherapy drug Temozolomide and blood pressure drug Nadolol. Temozolomide will be made available in six doses from 5 mg to 250 mg. It is used in the management of brain tumors. The market size of Temozolomide is estimated at […]
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 got approval from US authorities to launch a generic version of Daiichi Sankyo’s hypertension drug Azor in various dosages. The drug had annual sales of approximately $211.6 million as of May. The approval was obtained from United States Food & Drug Administration for Amlodipine and Olmesartan Medoxomil tablets in dosages ranging […]
Zydus Cadila has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Tablets used for controlling blood sugar levels. “This is a fixed dose combination of two anti-diabetic drugs indicated for Type II diabetes mellitus and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad,” […]
Zydus Cadila said it received the final approval to sell urine leakage drug Oxybutynin Chloride in the US market. The annual US sales of the drug is about $150.9 million, it said. The US FDA approved dosages of 5 mg, 10 mg, and 15mg. The drug is largely available in generic format. The medicine is […]
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 […]
Alembic Pharmaceuticals said it received approval from the US Food & Drug Administration for selling a generic equivalent of AstraZeneca’s heart drug Atacand. Approval was granted for the sale of candesantan cilexetil in the dosage of 32 mg. Candesartan cilexetil is used for treatment of hypertension in adults and children and treatment of heart failure. […]
Pharma Major Lupin said received final approval for launching a generic version of Mallinckrodt Inc.’s Roxicodone Tablets in the United States. The drug is used for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, the company said. Roxicodone Tablets has US sales of USD 344 […]
Generic drug manufacturer Unichem Laboratories said its formulations manufacturing facility at Ghaziabad has successfully exited an inspection by the US Food and Drug Administration. It received an Establishment Inspection Report (EIR) from the USFDA, the company said. “This receipt indicates the successful closure of the inspection and the queries raised during the audit (Form 483). […]
Zydus Cadila said the US Food and Drug Administration has given the final approval to market the company’s Mesalamine Delayed-Release Tablets in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for a generic version of Lialda. Lialda is indicated for the treatment of mild to moderate ulcerative […]
