Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (2024)

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11:00:52 27/05/2024 BST
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5,884 INR +0.34% Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (1) +1.20% +1.49%
12:16pm Indian drugmakers to see FY25 revenue boost in key US market, says India Ratings and Research RE
05-24 Dr. Reddy's Laboratories LLC, Russia Enters into Distribution Agreement with Novartis Pharma LLC CI

Dr. Reddy's Laboratories Ltd. and its subsidiary, Promius Pharma, LLC announced the approval of TOSYMRA (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company is working toward commercialization of this product.

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Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (2)

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Company Profile

Dr. Reddy's Laboratories specializes in developing, producing, and selling pharmaceutical products. Net sales break down by activity as follows:- sales of generic medications (79.9%): brand-name or generic prescription medications and OTC medicines;- sales of active ingredients (15.7%). The group also supplies customized pharmaceutical services;- other (4.4%): sales of generic biopharmaceutical products, development of molecular agents, etc.Net sales are distributed geographically as follows: India (18.8%), the United States (45%), Russia (9.9%) and other (26.3%).

Sector

Pharmaceuticals

Calendar

15/07/2024 - Ex-dividend day for final dividend

Related indices

NIFTY 50 , NIFTY 100

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Ratings for Dr. Reddy's Laboratories Limited

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Investor Rating

ESG Refinitiv

B+

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Analysts' Consensus

Sell

Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (3)

Buy

Mean consensus

HOLD

Number of Analysts

35

Last Close Price

5,884INR

Average target price

6,101INR

Spread / Average Target

+3.68%

Consensus

EPS Revisions

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Quarterly earnings - Rate of surprise

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Sector Other Pharmaceuticals

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DR. REDDY'S LABORATORIES LIMITED

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  5. Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market

Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (14)

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Dr. Reddy's Laboratories and Promius Pharma, Announces FDA Approval for TOSYMRA (Sumatriptan Nasal Spray) 10mg, in the U.S. Market (2024)

FAQs

Is sumatriptan nasal spray safe? ›

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks as well as the benefits of using this medicine. This medicine is available only with your doctor's prescription.

Can you buy sumatriptan nasal spray over the counter? ›

The nasal spray and injection are used to treat migraines and cluster headaches. The tablets are for migraines only. Sumatriptan is available on prescription. You can also buy packs containing two, 50mg tablets from a pharmacy without a prescription, but only if you have previously been diagnosed with migraines.

Does sumatriptan nasal spray cause bad taste in mouth? ›

A bitter taste was the most commonly reported side effect of sumatriptan nasal spray--reported by 68% (80 out of 118) of the migraineurs.

How long does sumatriptan nasal spray last? ›

The nasal spray usually works within 15 minutes. Each spray contains 1 dose (10mg or 20mg of sumatriptan). If your headache improves but then comes back, you can have another dose after 2 hours. If the first dose of sumatriptan does not help, do not take another dose for the same attack.

What is the new FDA approved nasal spray for migraines? ›

Zavzpret Is the First FDA-Approved Gepant Nasal Spray for Acute Migraine. Zavegepant is a type of migraine medication called a gepant. Gepants work to block CGRP, a protein that carries pain signals along nerves that are involved in generating the headache pain associated with migraine.

Why do I feel weird after taking sumatriptan? ›

You may experience pressure, tightness, or pain in your chest, neck, or jaw after taking a dose of sumatriptan. In most cases, this is temporary and unrelated to any heart problems. But don't ignore sudden or intense chest pain since it could be a sign of something more serious.

Is sumatriptan nasal spray being discontinued? ›

Sumatriptan has been available in Australia since the early 1990s. Currently, it is only available in Australia as an oral tablet or fast disintegrating tablet (as of February 2024). It was previously available as a nasal spray and injection, however these formulations have been discontinued by the manufacturer.

Which nasal spray is best for migraines? ›

Zolmitriptan nasal spray is used to treat acute migraine headaches in adults and children 12 years of age and older. It is not used to prevent migraine headaches and is not used for cluster headaches. Zolmitriptan works in the brain to relieve the pain from migraine headaches.

What are the cons of sumatriptan? ›

Side effects of sumatriptan Brand names: Imigran, Migraitan, Boots Migraine Relief
  • Feeling or being sick (nausea or vomiting) ...
  • Feeling dizzy, unsteady on your feet or tired. ...
  • Feeling hot or cold, face flushes red. ...
  • Irritation or burning in your nose or throat after using the nasal spray. ...
  • Nosebleeds after using the nasal spray.

Is it bad to take sumatriptan 3 days in a row? ›

You shouldn't take sumatriptan oral tablets on a regular daily basis. This drug can't prevent migraine. You should only take this medication when you need to treat a migraine headache. Don't take sumatriptan oral tablets on more than 4 days in any 30-day period.

Why is sumatriptan restricted? ›

This medicine may increase your risk of having abnormal heart rhythm, heart attack, angina, or stroke. This is more likely to occur if you or a family member already has heart disease, if you have diabetes, high blood pressure, high cholesterol, or if you smoke.

What can you not take with sumatriptan? ›

There are some medicines that may affect the way sumatriptan works. Tell your doctor if you're taking: other migraine or headache medicines (including ergotamine and other triptans) antidepressants, including SSRIs (selective serotonin reuptake inhibitors) or MAOIs (monoamine oxidase inhibitors)

What is the safest nasal decongestant spray? ›

Saline sprays provide gentle relief from congestion while moisturizing your nasal passages, and they're also safe for frequent use. Dr. Trenkle likes nasal sprays that contain xylitol because they have a cleansing effect, reducing the adherence of bacteria and irritants in the nasal passages.

Is sumatriptan nasal spray better than tablet? ›

The benefits of nasal spray is that it takes effects faster and enters your blood stream more directly than tablets. The 20 mg nasal spray works in about 15 minutes, making it twice as fast as a 100 mg dose of the tablet.

Who should avoid sumatriptan? ›

Use of sumatriptan is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

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