Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds’ Corgard heart drug. Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said. Lupin’s Nadolol Tablets are the AB rated generic equivalent of […]
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 […]
Pharma giant Glenmark Pharmaceuticals said it received final approval to sell skin oinment Desonide Lotion in the US. The ointment has annual sales of approximately $23.2 million. The medicine is used to treat eczema, dermatitis, allergies, rashes etc. Desonide reduces the swelling, itching and redness that can occur in these types of conditions. The United […]
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 Lupin said it received final approval from the US Food and Drug Administration for launching a generic version of Pfizer Inc.’s acne drug Vibra-Tabs. Doxycycline Hyclate Tablet 100 mg had US sales of USD 149.9 million per year, the company said. Doxycycline Hyclate is the AB rated generic equivalent of Pfizer Inc.’s Vibra-Tabs. […]
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 […]
The solar energy revolution may be all about saving the environment, but for the Indian state of Chhattisgarh, it’s impact is more immediate, and life-saving. According to a first-of-its-kind study conducted on primary health centers in the state, PHCs with solar backup admitted 50% more patients and conducted almost twice the number of child deliveries […]
Pharma giant Dr Reddy’s Labs today said that a class action lawsuit has been filed against it on behalf of shareholders, alleging that the company misled investors causing them to lose money on their investments. “The lawsuit alleges that the company made materially false and/or misleading statements or omissions in connection with its corporate quality […]
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 […]
Aurobindo Pharma said it received tentative approval for its for anti-HIV drug Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate under the U.S. President’s Emergency Plan for AIDS Relief or PEPFAR. The approved product is used for the treatment of HIV-1 infection along as a complete regimen in adults and pediatric patients weighing 40 kg and greater. […]
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 […]
About 10.6% of adults in India suffer from some sort of mental disorder, including substance abuse problems, a study by the National Institute of Mental Health and Neurosciences or NIMHANS found. The study was conducted in 12 states of India by the Bangalore-based institution. Those with mental disorders were classified as those with ‘common mental […]
The number of people getting infected with measles, a deadly disease that causes a red rash and is spread through the air, has shown a steady increase in four adjoining states of North India, as well as Gujarat. Measles is a highly contagious infection caused by the measles virus and can cause complications such as […]
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 […]
