Latest News | Alembic Pharma Gets USFDA Nod for Erectile Dysfunction Drug
Get latest articles and stories on Latest News at LatestLY. Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Vardenafil Hydrochloride tablets, indicated for the treatment of erectile dysfunction.
New Delhi, Aug 5 (PTI) Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Vardenafil Hydrochloride tablets, indicated for the treatment of erectile dysfunction.
The approved product is therapeutically equivalent to the reference listed drug product Levitra tablets of Bayer Healthcare Pharmaceuticals Inc.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA)Vardenafil Hydrochloride tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, Alembic Pharmaceuticals said in a BSE filing.
Quoting IQVIA data, the company said, Vardenafil Hydrochloride tablets have an estimated market size of USD 35 million for twelve months ending June 2020.
Alembic now has a total of 127 ANDA approvals (112 final approvals and 15 tentative approvals) from USFDA.
Shares of Alembic Pharmaceuticals were trading 0.31 per cent higher at Rs 1,020.30 apiece on the BSE. PTI SVK DRR DRR 08051113 NNNNtive for COVID-19 just hours before kickoff.
The league suspended only the game affected by the outbreak and not the entire final round, igniting complaints and threats of legal actions by other clubs that felt they were hurt by the decision.
The playoffs had been on hold since then as officials, local authorities and club directors exchanged accusations and made demands.
Elche on Monday maintained the integrity of the competition was affected and said it would continue to fight for its rights. It claimed it wouldn't be fair for Fuenlabrada to face a Deportivo team with no interest left in the competition.
There had already been reports that Deportivo's players had not showed up for coronavirus tests scheduled by the league this week.
In a statement, Elche also noted the Spanish league declared Elche would be participating in the playoffs.
The league requested the Deportivo-Fuenlabrada match to be canceled after the number of Fuenlabrada team members who tested positive reached 28 about a week ago. The club said this week it still wanted to play the match and would have enough players available.
"These players earned the right to play, but a pandemic interfered," Sandoval said.
"It's only fair that this game is played."
The federation competition committee noted Deportivo was against playing Wednesday's game. The 2000 Spanish league champion wanted next season's second division to be played with 24 teams instead of 22, allowing it to avoid relegation.
Espanyol, relegated from the first division, said on Monday it wanted the league to eliminate demotion in all divisions because of the problems caused by pandemic.
"The financial impact of COVID-19 will continue into the 2020-21 season," Espanyol said in a statement.
"And with the added financial impact of relegation, this double punishment would be devastating and unfair."
The Spanish federation last weekend suspended fourth-division matches after players in a team participating in the promotion playoffs tested positive for COVID-19. The second-division promotion playoffs are now set to end on Aug. 23. (AP)
(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)