Global healthcare company Sanofi and Regeneron Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection to patients suffering from chronic and debilitating form of eczema.
"Aurobindo's Guaifenesin and Dextromethorphan Hydrobromide extended-release tablets are the AB rated generic equivalent of Reckitt Benckiser's Mucinex DM tablets. The product will be launched in Q1 FY18 (in US)," it said.
"The company has received final approval from the US Food and Drug Administration (USFDA) to market tizanidine hydrochloride capsules, USP in strengths of 2mg, 4mg and 6mg," Zydus Cadila said in a regulatory filing today.
Analysts believe that Neuland Labs is a supplier of API (active pharma ingredient) to Teva for this drug, which is used in the therapy of Huntington Disease, a disorder related to tardive dyskinesia. If the new drug application is accepted, Neuland will be a key beneficiary.
Suprep follows a split dose regime and Lupin has got approval for Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, all of which are taken to cleanse the colon before colonoscopy in adults. Suprep Bowel Prep Kit has a market of $207 mn in the USA.
The company has received approval from the US Food and Drug Administration (USFDA) for Itraconazole capsules, a generic version of Janssen Pharmaceuticals' Sporanox, Jubilant Life Sciences said in a regulatory filing.
The US drug regulator has made six observations after the completion of inspection of its Kothur formulation facility in Telangana, Natco said today in a statement.
The company said it has launched the morphine sulfate ER Tablets in strengths of 15 mg, 30 mg, 60 mg, 100 mg and 200 mg having received an approval from the US Food and Drug Administration (USFDA).
US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.
Valuation in the information technology sector is favourable but challenges in terms of earnings and uncertainty on Trump‘s policies make them good picks only on bad days, says Nischal Maheshwari, Head - Institutional Equities at Edelweiss Securities.
According to a statement issued by the city-based drug-maker, the drug will be launched along with its marketing partner Breckenridge Pharmaceutical Inc and will have 180-days exclusivity.
USFDA has already banned import of products from the facility into the US market since August 5, 2016.
Divis' Unit 2 facility was last inspected in February 2016 with no form 483s being issued. The company's Unit 1 facility (located at Hyderabad) has no pending 483s (but was last inspected in 2014).
The demonetisation drive has taken a toll on the market and Anish Damania of IDFC Securities says that the market may not see recovery soon and there will be three quarters of dismay.
Pharmaceutical stocks have traditionally been considered defensive safe havens because demand for medicines doesn‘t depend on the economic cycle
"You can get better tax compliance, arguably lower corruption. If you have higher tax compliance, you might get lower tax rates," Dipen Sheth said.
Earlier this month, Sun said it had been informed by the US health regulator of more concerns about its plant in the western Indian state of Gujarat after a recent inspection, but details of the violations were unclear at the time.
The latest notice, a Form 483, was issued to Sun after the FDA completed an inspection of the Halol plant on Dec. 1, the company said. Such a notice is issued when the FDA finds that conditions at a drug plant violate US rules.
In the past few weeks, CDSCO has inspected around 135 manufacturing plants and laboratories all over the country with help from state regulators. The regulator's main focus is to assess the risk and quality standards of manufacturing units.
The company has received EIR from the US Food and Drug Administration (USFDA) indicating the formal closure of the cGMP and pre-approval inspection conducted at its oncology parenteral and oral solids dosage formulation facilities at Baddi, Panacea Biotec said in a BSE filing.
Biotechnology major Biocon reported 19.8 percent rise in revenue to Rs 796.2 crore year-on-year and margins grew to 25.2 percent from 21.2 percent in the second quarter of FY17. The company‘s standalones sale grew 17 percent in Q2.
The drug, a therapeutic equivalent generic version of Abilify (Aripiprazole) tablets, has been introduced in the world's biggest pharma market after getting approval from the US Food and Drug Administration (USFDA), the city-based company said in a statement.
The recall has been initiated by Sun Pharmaceutical Industries Inc for 31,762 bottles of bupropion hydrochloride extended-release tablets, USP (SR) in the strength of 150 mg, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.
"The company's formulation facility located at Panelav has received the Establishment Inspection Report (EIR) from US Food and Drug Administration (FDA) for the inspection carried out by them in March 2016," Alembic Pharmaceuticals said in a BSE filing.
Aurobindo Pharma gained 1.4 percent and Shilpa Medicare rallied 3.4 percent intraday Tuesday after getting approval from the US health regulator for HIV and chemotherapy drugs, respectively.